MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-12-20 for 5FR GRASPER FORCEP GYA-5 manufactured by Gyrus Acmi Inc..
[4184150]
Olympus was informed that during iud retrieval, the tip of the grasper (where it clamps together) broke off and fell inside the pt. The broken tip was retrieved with an unk instrument. The procedure was completed with another instrument. There was no pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
[11622333]
The device was not returned to olympus for eval. The user's experience cannot be conclusively determined. If add'l and significant info becomes available at a later date, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951238-2013-00114 |
| MDR Report Key | 3642910 |
| Report Source | 06 |
| Date Received | 2013-12-20 |
| Date of Report | 2013-12-04 |
| Date of Event | 2013-12-04 |
| Date Mfgr Received | 2013-12-04 |
| Date Added to Maude | 2014-04-03 |
| 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 | LAURA STORMS |
| Manufacturer Street | 2400 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4848965688 |
| Manufacturer G1 | GYRUS AMCI INC. |
| Manufacturer Street | 136 TURNPIKE ROAD |
| Manufacturer City | SOUTHBOROUGH MA 01772210 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01772 2104 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 5FR GRASPER FORCEP |
| Generic Name | FORCEPS |
| Product Code | HIN |
| Date Received | 2013-12-20 |
| Model Number | GYA-5 |
| Catalog Number | GYA-5 |
| Lot Number | NA |
| 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 INC. |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772210 US 01772 2104 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-20 |