Devices › Motor, surgical instrument, pneumatic powered
Device brand name · Disposable surgical accessory
Roticulator Endo Grasp 5mm W/Spin Lock: medical device reports filed with FDA
201 reports name it, 2006–2016. Manufacturer given most often on reports: Ussc Puerto Rico. Product code GET.
- 201
- device reports naming the brand
- 0% of all MAUDE reports · about 10 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 96.5%
- classified as malfunction
- 91.2% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 201 reports that name the brand "Roticulator Endo Grasp 5mm W/Spin Lock" (disposable surgical accessory), received between June 2006 and September 2016; the manufacturer given most often on reports is Ussc Puerto Rico. 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 (96.5%) and injury (3.5%); across all motor, surgical instrument, pneumatic powered reports (product code GET) death is recorded in 0.1% and malfunction in 91.2%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (32.8%), component falling (12.4%) and detachment of device component (10.9%). The patient problems coded most often are foreign body, removal of, hemorrhage/blood loss/bleeding and no patient involvement. 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 Roticulator Endo Grasp 5mm W/Spin Lock was received in the five years to August 2026; the latest was received in September 2016.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 1,030 reports carrying product code GET. 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 | 66 | 32.8% | 14.3% |
| Component falling | 25 | 12.4% | 2.7% |
| Detachment of device component | 22 | 10.9% | 4.6% |
| Torn material | 22 | 10.9% | 1.7% |
| Split | 16 | 8% | 0.9% |
| Crackthe device cracked | 11 | 5.5% | 1.3% |
| Material frayed | 11 | 5.5% | 0.6% |
| Difficult to removethe device was hard to remove | 10 | 5% | 0.4% |
| Peeled/delaminated | 8 | 4% | 1.8% |
| Device, removal of (non-implant) | 7 | 3.5% | 0.9% |
| Sticking | 6 | 3% | 4.4% |
| Device operates differently than expectedthe device behaved unexpectedly | 4 | 2% | 1.7% |
| Difficult to open or close | 4 | 2% | 4.5% |
| Material separation | 4 | 2% | 0.3% |
| Positioning problem | 4 | 2% | 0.2% |
| Replace | 3 | 1.5% | 1.7% |
| Component(s), broken | 2 | 1% | 2.5% |
| Detachment of device or device componentpart of the device came off | 2 | 1% | 2.1% |
| Failure to align | 2 | 1% | 8% |
| Malposition of device | 2 | 1% | 0.2% |
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 | 3.5% |
| Hemorrhage/blood loss/bleeding | 6 | 3% |
| No patient involvement | 6 | 3% |
| Device embedded in tissue or plaque | 2 | 1% |
| Tissue damage | 2 | 1% |
| Nonresorbable materials, unretrieved in body | 1 | 0.5% |
| Partial thickness (second degree) burn | 1 | 0.5% |
| Surgical procedure, delayed | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Roticulator Endo Grasp 5mm W/Spin Lock | Product code GET | All MAUDE reports |
|---|---|---|---|
| Reports | 201 | 1,030 | 26,136,888 |
| Share of that pool | — | 19.5% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 3.5% | 5.8% | 36.2% |
| Classified as malfunction | 96.5% | 91.2% | 62.3% |
| Filed by the manufacturer | 100% | 98.3% | 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 GET
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Pin Collet | 408 | 0 | 0% |
| Wire Collet | 328 | 3 | 0% |
| Sagittal Saw Attachment | 1,505 | 64 | 0% |
| Cordless Driver 2 Handpiece | 155 | 0 | 0% |
| Cordless Driver 3 | 476 | 0 | 0% |
| Microaire | 176 | 0 | 0.6% |
| Ultracision Surg Dev Curved Shears Endo | 1,586 | 0 | 0% |
| Universal Drill | 210 | 0 | 0% |
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 Roticulator Endo Grasp 5mm W/Spin Lock reports
How many FDA reports name Roticulator Endo Grasp 5mm W/Spin Lock?
201 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 (96.5%) and injury (3.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (32.8%), component falling (12.4%), detachment of device component (10.9%), torn material (10.9%) and split (8%). 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 Roticulator Endo Grasp 5mm W/Spin Lock 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.