MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06,07 report with the FDA on 2013-03-25 for SEMI-RIGID ALLIGATOR FORCEPS GYA-5 manufactured by Gyrus Acmi L.p..
[17932325]
During a hysteroscopic procedure, the tip of the grasper broke off inside the pt. The surgeon was able to retrieve the instrument tip in one piece. There was no harm to the pt.
Patient Sequence No: 1, Text Type: D, B5
[18052931]
The instrument was sent to a 3rd party repair facility, the tip was saved, but the note for it was lost, so the piece was ultimately thrown out. The 3rd party repair facility could not repair the device so it was shipped back to the hospital where it was then thrown out. As a result, a determination cannot be made at this time. If further information becomes available, gyrus (b)(4) will continue the investigation and update the agency accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005975494-2013-00005 |
| MDR Report Key | 3077747 |
| Report Source | 00,06,07 |
| Date Received | 2013-03-25 |
| Date of Report | 2013-03-14 |
| Date of Event | 2013-02-21 |
| Date Mfgr Received | 2013-03-14 |
| Date Added to Maude | 2013-04-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. TERRENCE SULLIVAN |
| Manufacturer Street | 136 TURNPIKE ROAD |
| Manufacturer City | SOUTHBOROUGH MA 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 5088042739 |
| Manufacturer G1 | GYRUS ACMI L.P. |
| Manufacturer Street | 6845 WEDGEWOOD RD. |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55311 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SEMI-RIGID ALLIGATOR FORCEPS |
| Generic Name | SEMI-RIGID ALLIGATOR FORCEPS |
| Product Code | HIN |
| Date Received | 2013-03-25 |
| Model Number | GYA-5 |
| Catalog Number | GYA-5 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI L.P. |
| Manufacturer Address | 6845 WEDGEWOOD RD. MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-03-25 |