MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-28 for ENDOJAW DISPOSABLE BIOPSY FORCEPS FH-211D manufactured by Olympus Medical Systems Corp..
[129031302]
During the procedure, the biopsy forceps were opened, but unable to close, the outer cups remained open despite closing the forceps. The inner prongs of the biopsy forceps that helps the outer cups to open came out. The prongs remained intact as well as the outer cups. The forceps were gently removed from the scope. Leak test was performed and was negative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081692 |
| MDR Report Key | 8115446 |
| Date Received | 2018-11-28 |
| Date of Report | 2018-11-16 |
| Date of Event | 2018-11-12 |
| Date Added to Maude | 2018-11-29 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | ENDOJAW DISPOSABLE BIOPSY FORCEPS |
| Generic Name | FORCEPS BIOPSY ELECTRIC |
| Product Code | KGE |
| Date Received | 2018-11-28 |
| Model Number | FH-211D |
| Lot Number | 86V |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HANCHIOJI-SHI TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-28 |