Reported Reactions

Devices › System, surgical, computer controlled instrument

Device brand name · Endoscopic instrument

Tenaculum Forceps Instrument: medical device reports filed with FDA

354 reports name it, 2007–2016. Manufacturer given most often on reports: Intuitive Surgical. Product code NAY.

354
device reports naming the brand
0% of all MAUDE reports · about 18 a year
0
reports, 12 months to August 2026
0 in the 12 months before
98%
classified as malfunction
90.7% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

354 medical device reports received by FDA name the brand "Tenaculum Forceps Instrument" (endoscopic instrument); the manufacturer given most often on reports is Intuitive Surgical; received from February 2007 to October 2016. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

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%), injury (1.4%) and other (0.6%); 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 (53.4%), material frayed (7.1%) and device operates differently than expected (6.8%). The patient problems coded most often are foreign body in patient, foreign body, removal of and hemorrhage/blood loss/bleeding. 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 Tenaculum Forceps Instrument was received in the five years to August 2026; the latest was received in October 2016.

By year received

0721442007: 620072008: 2120082009: 720092010: 420102011: 320112012: 3320122013: 14420132014: 10920142015: 2320152016: 42016

Event type and report source

Event type, as classified on the report

Death0%0
Injury1.4%5
Malfunction98%347
Other0.6%2
Not given0%0

Who filed the report

Manufacturer report100%354
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

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)ReportsShareShare across product code
Breakthe device broke18953.4%10.3%
Material frayed257.1%7.7%
Device operates differently than expectedthe device behaved unexpectedly246.8%1.4%
Material protrusion/extrusion174.8%0.4%
Detachment of device component133.7%0.9%
Device slipped113.1%0.2%
Component falling82.3%0.6%
Difficult to open or close82.3%4.5%
Loose or intermittent connection61.7%0.2%
Bent51.4%0.2%
Material separation51.4%0.6%
Device inoperablethe device could not be used41.1%0.3%
Positioning problem30.8%0.4%
Crackthe device cracked20.6%0.2%
Detachment of device or device componentpart of the device came off20.6%5%
Device displays incorrect message20.6%1%
Device, removal of (non-implant)20.6%0%
Insufficient device problem information20.6%1.1%
Material fragmentation20.6%5.7%
Replace20.6%0.1%

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)ReportsShare
Foreign body in patientpart of a device left in the patient20.6%
Foreign body, removal of10.3%
Hemorrhage/blood loss/bleeding10.3%
Surgery, prolonged10.3%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureTenaculum Forceps InstrumentProduct code NAYAll MAUDE reports
Reports354141,00026,136,888
Share of that pool—0.3%0%
Classified as death, per 1,000 reports069
Classified as injury1.4%7.9%36.2%
Classified as malfunction98%90.7%62.3%
Filed by the manufacturer100%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

BrandReportsLatest 12 monthsClassified as death
Endowrist86,56637,1920%
daVinci Xi15,7225,7432%
daVinci 52,3942,1220.7%
Fenestrated Bipolar Forceps Instrument1,83900%
EndoWrist;daVinci Si1,7713560.1%
Pk Dissecting Forceps Instrument1,56400%
Da Vinci Si Surgical System1,461011%
Prograsp Forceps Instrument1,39600%
EndoWrist SP1,3555970%
da Vinci1,4834041.2%
daVinci Si1,2251292.3%
daVinci X9384205.4%
Maryland Bipolar Forceps Instrument95200%
SureForm2,9276541.2%
Monopolar Curved Scissors Instrument1,05600%

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 Tenaculum Forceps Instrument reports

How many FDA reports name Tenaculum Forceps Instrument?

354 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%), injury (1.4%) and other (0.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

break (53.4%), material frayed (7.1%), device operates differently than expected (6.8%), material protrusion/extrusion (4.8%) and detachment of device component (3.7%). 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 Tenaculum 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.