MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-01 for ALLIGATOR BX FORCEPS HYSTEROSCOPE ACCESSORIES FB-211D 6ZK manufactured by Olympus - Roswell.
[74417658]
Alligators bx. Forceps (item#88331) model #fb-211d 6zk exp 2021 forceps were applied to endobronchial tissue and tissue removed. Scrub opened forceps to release tissue and wire protruded from and of forceps. Forceps would no longer open or close. Scrub reported that earlier the forceps were slow to open and close.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069525 |
| MDR Report Key | 6541090 |
| Date Received | 2017-05-01 |
| Date of Report | 2017-05-01 |
| Date of Event | 2017-04-14 |
| Date Added to Maude | 2017-05-03 |
| 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 | ALLIGATOR BX FORCEPS HYSTEROSCOPE ACCESSORIES |
| Generic Name | ALLIGATOR BX FORCEPS HYSTEROSCOPE ACCESSORIES |
| Product Code | NWW |
| Date Received | 2017-05-01 |
| Model Number | FB-211D 6ZK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS - ROSWELL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-01 |