MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-07-20 for FLETCHER-VAN DOREN UTERINE FORCEPS GL1805 manufactured by August Rechlen.
[120257]
At the end of the procedure a piece of the jaw from the uterine polyp forceps was noted to be missing. A search of the area and specimen, tissue, pelvic exam did not reveal broken part. Flat plate pelvic x-ray post-procedure did not reveal the missing piece in pt. The broken part was not found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000008-1998-00007 |
| MDR Report Key | 179424 |
| Date Received | 1998-07-20 |
| Date of Report | 1998-07-20 |
| Date of Event | 1998-05-11 |
| Date Facility Aware | 1998-05-12 |
| Report Date | 1998-07-20 |
| Date Reported to FDA | 1998-07-20 |
| Date Reported to Mfgr | 1998-05-14 |
| Date Added to Maude | 1998-07-30 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLETCHER-VAN DOREN UTERINE FORCEPS |
| Generic Name | INSTRUMENT |
| Product Code | HCZ |
| Date Received | 1998-07-20 |
| Returned To Mfg | 1998-05-22 |
| Model Number | GL1805 |
| Catalog Number | GL1805 |
| Lot Number | N |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 7 DAY |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 174457 |
| Manufacturer | AUGUST RECHLEN |
| Manufacturer Address | JUNKERSTRASSE 8 TUTTLINGEN GM D78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-07-20 |