MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-04-03 for PKS CUT FORCEPS, 5MM, 33CM, 9-PIN 920005PK manufactured by Gyrus Acmi Inc.
[4403342]
The user facility reported that during a laparoscopic supracervical hysterectomy the physician wasn't aware that the device was intermittently coagulating and would cut tissue as the pt had a very large coagulation. The pt lost 100cc's of blood from a bleeder and had to be given a unit of blood from a bleeder and had to be given a unit of blood. Another device was opened which also failed. The case was finished using a third device. Olympus has attempted to follow up to obtain further info regarding the pt's condition but no info has been made available.
Patient Sequence No: 1, Text Type: D, B5
[11741452]
The cutting forceps were returned to olympus for evaluation. Evaluation confirmed the complaint. Visual inspection found the insulation damaged on all four electrodes and the flare cracked in four places where the electrode humps start to enter the shaft when the jaws were closed. The jaws open/close, the blad advances/retracts and the lock functions as designed. The bare sports on the electrodes were shorting cut on the shaft where the flare was cracked. The root cause was inconclusive and unable to be determined. The device history record showed no discrepancies.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951238-2014-00164 |
| MDR Report Key | 3824484 |
| Report Source | 06,07 |
| Date Received | 2014-04-03 |
| Date of Report | 2014-03-20 |
| Date of Event | 2014-03-20 |
| Date Mfgr Received | 2014-03-20 |
| Date Added to Maude | 2014-05-22 |
| 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 951311700 |
| Manufacturer Country | US |
| Manufacturer Postal | 951311700 |
| Manufacturer Phone | 4089355002 |
| Manufacturer G1 | GYRUS ACMI INC |
| Manufacturer Street | 136 TURNPIKE RD |
| 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 CUT FORCEPS, 5MM, 33CM, 9-PIN |
| Generic Name | FORCEPS |
| Product Code | HFB |
| Date Received | 2014-04-03 |
| Returned To Mfg | 2014-03-26 |
| Model Number | 920005PK |
| Catalog Number | 920005PK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI INC |
| Manufacturer Address | 136 TURNPIKE RD SOUTHBOROUGH MA 01772210 US 01772 2104 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 920005 | 1. Required No Informationntervention | 2014-04-03 |