MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-06 for ENDOCLOSE BERCI FORCEP manufactured by Unk.
[126880153]
During closure of the abdomen, the endoclose berci forcep was introduced into the abdomen and after which it was observed that the sharp point (lower jaw) of the instrument was missing. The abdomen was visually scanned with the laparoscope to look for the lower jaw, it was not seen. The incision site was examined and the complete lower jaw was found in the subcutaneous tissue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081139 |
| MDR Report Key | 8046620 |
| Date Received | 2018-11-06 |
| Date of Report | 2018-11-05 |
| Date of Event | 2018-10-09 |
| Date Added to Maude | 2018-11-07 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | ENDOCLOSE BERCI FORCEP |
| Generic Name | ENDOSCOPE AND/OR ACCESSORIES |
| Product Code | GCP |
| Date Received | 2018-11-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-11-06 |