MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-04-15 for PKS CUTTING FORCEPS 920005PK manufactured by Gyrus Acmi Inc..
[4436252]
The user facility reported that during a laparoscopic hysterectomy the device would not coagulate. A second device was opened and would also not coagulate. Patient injury was reported, however, the customer would not provide details as to the extent of the injury. The procedure was not completed. Olympus followed up with the user facility to obtain add'l info but no further info has been provided.
Patient Sequence No: 1, Text Type: D, B5
[11749218]
The device referenced in this report has not been returned to olympus for evaluation. If add'l info or if the device is rec'd at a later time this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951238-2014-00180 |
| MDR Report Key | 3779033 |
| Report Source | 06,07 |
| Date Received | 2014-04-15 |
| Date of Report | 2014-03-28 |
| Date of Event | 2014-03-28 |
| Date Mfgr Received | 2014-03-28 |
| Device Manufacturer Date | 2013-12-01 |
| Date Added to Maude | 2014-05-01 |
| 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 | NOEMI SCHAMBACH |
| Manufacturer Street | 2400 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355002 |
| Manufacturer G1 | GYRUS ACMI 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 | PKS CUTTING FORCEPS |
| Generic Name | FORCEPS |
| Product Code | HFB |
| Date Received | 2014-04-15 |
| Model Number | 920005PK |
| Catalog Number | 920005PK |
| Lot Number | JF811058 |
| 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 | 1. Required No Informationntervention | 2014-04-15 |