Devices › System, surgical, computer controlled instrument
Device brand name · Endoscopic electrosurgical instrument
Pk Dissecting Forceps Instrument: medical device reports filed with FDA
1,564 reports name it, 2007–2016. Manufacturer given most often on reports: Intuitive Surgical. Product code NAY.
- 1,564
- device reports naming the brand
- 0% of all MAUDE reports · about 81 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 98.8%
- classified as malfunction
- 90.7% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 1,564 reports that name the brand "Pk Dissecting Forceps Instrument" (endoscopic electrosurgical instrument), received between March 2007 and November 2016; the manufacturer given most often on reports is Intuitive Surgical. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (98.8%), injury (0.7%) and other (0.3%); across all system, surgical, computer controlled instrument reports (product code NAY) death is recorded in 0.6% and malfunction in 90.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (44.1%), material frayed (17.6%) and device operates differently than expected (5.9%). The patient problems coded most often are foreign body, removal of, no patient involvement and device embedded in tissue or plaque. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
No report naming Pk Dissecting Forceps Instrument was received in the five years to August 2026; the latest was received in November 2016.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 141,000 reports carrying product code NAY. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Breakthe device broke | 689 | 44.1% | 10.3% |
| Material frayed | 276 | 17.6% | 7.7% |
| Device operates differently than expectedthe device behaved unexpectedly | 93 | 5.9% | 1.4% |
| Material protrusion/extrusion | 72 | 4.6% | 0.4% |
| Failure to align | 68 | 4.3% | 0.3% |
| Difficult to open or close | 46 | 2.9% | 4.5% |
| Loose or intermittent connection | 41 | 2.6% | 0.2% |
| Material separation | 35 | 2.2% | 0.6% |
| Device inoperablethe device could not be used | 33 | 2.1% | 0.3% |
| Detachment of device component | 32 | 2% | 0.9% |
| Bent | 26 | 1.7% | 0.2% |
| Component falling | 25 | 1.6% | 0.6% |
| Device slipped | 21 | 1.3% | 0.2% |
| Positioning problem | 16 | 1% | 0.4% |
| Sticking | 15 | 1% | 0.2% |
| Malposition of device | 8 | 0.5% | 0.1% |
| Component missing | 7 | 0.4% | 0.1% |
| Device issuea problem with the device | 7 | 0.4% | 0% |
| Insufficient device problem information | 6 | 0.4% | 1.1% |
| Looping | 6 | 0.4% | 0% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Foreign body, removal of | 7 | 0.4% |
| No patient involvement | 5 | 0.3% |
| Device embedded in tissue or plaque | 4 | 0.3% |
| Burn, thermal | 2 | 0.1% |
| Hemorrhage/blood loss/bleeding | 2 | 0.1% |
| Nonresorbable materials, unretrieved in body | 2 | 0.1% |
| Surgery, prolonged | 2 | 0.1% |
| Tissue damage | 2 | 0.1% |
| Burn(s)a burn | 1 | 0.1% |
| Failure to anastomose | 1 | 0.1% |
| Other (for use when an appropriate patient code cannot be identified) | 1 | 0.1% |
| Perforation of vessels | 1 | 0.1% |
| Physical entrapment | 1 | 0.1% |
| Skin discoloration | 1 | 0.1% |
| Therapy/non-surgical treatment, additional | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Pk Dissecting Forceps Instrument | Product code NAY | All MAUDE reports |
|---|---|---|---|
| Reports | 1,564 | 141,000 | 26,136,888 |
| Share of that pool | — | 1.1% | 0% |
| Classified as death, per 1,000 reports | 0 | 6 | 9 |
| Classified as injury | 0.7% | 7.9% | 36.2% |
| Classified as malfunction | 98.8% | 90.7% | 62.3% |
| Filed by the manufacturer | 100% | 97.1% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code NAY
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Endowrist | 86,566 | 37,192 | 0% |
| daVinci Xi | 15,722 | 5,743 | 2% |
| daVinci 5 | 2,394 | 2,122 | 0.7% |
| Fenestrated Bipolar Forceps Instrument | 1,839 | 0 | 0% |
| EndoWrist;daVinci Si | 1,771 | 356 | 0.1% |
| Da Vinci Si Surgical System | 1,461 | 0 | 11% |
| Prograsp Forceps Instrument | 1,396 | 0 | 0% |
| EndoWrist SP | 1,355 | 597 | 0% |
| da Vinci | 1,483 | 404 | 1.2% |
| daVinci Si | 1,225 | 129 | 2.3% |
| daVinci X | 938 | 420 | 5.4% |
| Maryland Bipolar Forceps Instrument | 952 | 0 | 0% |
| SureForm | 2,927 | 654 | 1.2% |
| Monopolar Curved Scissors Instrument | 1,056 | 0 | 0% |
| Da Vinci S Surgical System | 815 | 0 | 7.6% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Pk Dissecting Forceps Instrument reports
How many FDA reports name Pk Dissecting Forceps Instrument?
1,564 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (98.8%), injury (0.7%) and other (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (44.1%), material frayed (17.6%), device operates differently than expected (5.9%), material protrusion/extrusion (4.6%) and failure to align (4.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Pk Dissecting Forceps Instrument was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.