MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-05 for EVEREST BICOAG MACRO JAW FORCEPS 3600 manufactured by Gyrus Acmi.
[79519521]
Surgeon was using the gyrus acmi everest bicoag marco jaw forceps (lot # pw303457) and after a few uses jaws would not close all the way. This instrument was removed from the field and another one was opened to use. The next one (lot# jfg651294) did the same thing. A third "like" device was opened and functioned properly for the remainder of the procedure. Tissue with two separate like devices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070842 |
| MDR Report Key | 6692820 |
| Date Received | 2017-07-05 |
| Date of Report | 2017-07-05 |
| Date of Event | 2017-05-11 |
| Date Added to Maude | 2017-07-07 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EVEREST BICOAG MACRO JAW FORCEPS |
| Generic Name | LAPAROSCOPIC BIPOLAR FORCEPS |
| Product Code | GEN |
| Date Received | 2017-07-05 |
| Model Number | 3600 |
| Catalog Number | 3600 |
| Lot Number | PW303457 |
| Device Expiration Date | 2019-12-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI |
| Manufacturer Address | SOUTHBOROUGH MA 01772 US 01772 |
| Brand Name | EVEREST BICOAG MACRO JAW FORCEPS |
| Generic Name | LAPAROSCOPIC BIPOLAR FORCEPS |
| Product Code | GEN |
| Date Received | 2017-07-05 |
| Lot Number | JF651294 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI |
| Manufacturer Address | SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-05 |