MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-15 for OLYMPUS UROLOGY RESECTOSCOPE FOR 24 FR A22041A manufactured by Olympus.
[133375615]
Pt undergoing turp noted to have significant bleeding at the end of procedure. Situation addressed by urologist resectoscope removed and 3 way foley catheter placed with the inflation of the balloon to stop bleeding. When the resectoscope was being disassembled, it was noted that the beak of the resectoscope had fractured and a piece broken off. A search for the piece was done in the room including in the trash and specimen, but was not found. Fluoroscopy was performed and intact resectoscope in the field for comparison but the fragment was not found in the pt. Decision was made not to perform cystoscopy to search for the fragment. The bleeding was controlled and a ct scan was performed later that afternoon which was confirmed by radiology to not have any evidence of a retained resectoscope beak fragment. Disclosure made to pt and family. Per urology, there have been three cases where the beak on the resectoscope either came off or fractured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083115 |
| MDR Report Key | 8252784 |
| Date Received | 2019-01-15 |
| Date of Report | 2019-01-11 |
| Date of Event | 2018-11-08 |
| Date Added to Maude | 2019-01-16 |
| 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 | OLYMPUS UROLOGY RESECTOSCOPE FOR 24 FR |
| Generic Name | RESECTOSCOPE |
| Product Code | FDC |
| Date Received | 2019-01-15 |
| Model Number | A22041A |
| Lot Number | 184W-0015 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS |
| Manufacturer Address | HAMBURG 22045 GM 22045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-15 |