MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-04-15 for OVAL CUP BIOPSY FORCEPS, 1.8 MM X 130 CM 808 manufactured by Bard Endoscopy Div. C.r. Bard, Inc..
[16613191]
During bronchoscopy, transbronchial biopsy, a small (approx 2 mm) piece of the forcep jaw broke off in the left lower lobe of the lung; unable to remove.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1001617 |
| MDR Report Key | 12792 |
| Date Received | 1994-04-15 |
| Date of Report | 1994-04-04 |
| Date of Event | 1994-03-31 |
| Date Added to Maude | 1994-04-19 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OVAL CUP BIOPSY FORCEPS, 1.8 MM X 130 CM |
| Product Code | BWH |
| Date Received | 1994-04-15 |
| Catalog Number | 808 |
| Lot Number | 88HD0001 |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 12792 |
| Manufacturer | BARD ENDOSCOPY DIV. C.R. BARD, INC. |
| Manufacturer Address | MURRAY HILL NJ 07974 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-04-15 |