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..
[4468202]
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 uterus. The pt had severe bleeding due to poor coagulation. The pt lost 100cc's 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 information regarding the pt's condition but no information has been made available.
Patient Sequence No: 1, Text Type: D, B5
[11853337]
The device referenced in this report was discarded by the user facility and will not be returned to olympus for evaluation. If additional information is received at a later time this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951238-2014-00152 |
| MDR Report Key | 3767365 |
| 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 | 2014-04-24 |
| 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 CUT FORCEPS, 5MM, 33CM, 9-PIN |
| Generic Name | FORCEPS |
| Product Code | HFB |
| Date Received | 2014-04-03 |
| Model Number | 920005PK |
| Catalog Number | 920005PK |
| Lot Number | UNK |
| 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 | 2014-04-03 |