MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-08 for BIPOLAR RESECTOSCOPE A22042A manufactured by Olympus Corporation Of The Americas.
[59390609]
Patient Sequence No: 1, Text Type: N, H10
[59390610]
The physician opted for transurethral resection of prostate (turp) due to issues of visualization of the green light laser. The physician proceeded with olympus continuous flow resectoscope set. It was noted that the loop was not cutting correctly and it was not retracting completely. During the resection, the physician noted a foreign body in the bladder. Upon examination it was the white plastic tip of the resectoscope. The physician attempted to retrieve the plastic tip that was in the bladder but due to poor visualization post-turp, could not retrieve it. Patient can currently urinate and wants to leave it in unless a problem occurs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6084913 |
| MDR Report Key | 6084913 |
| Date Received | 2016-11-08 |
| Date of Report | 2016-11-04 |
| Date of Event | 2016-10-26 |
| Report Date | 2016-11-04 |
| Date Reported to FDA | 2016-11-04 |
| Date Reported to Mfgr | 2016-11-04 |
| Date Added to Maude | 2016-11-08 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Brand Name | BIPOLAR RESECTOSCOPE |
| Generic Name | CYSTOURETHROSCOPE |
| Product Code | FBO |
| Date Received | 2016-11-08 |
| Catalog Number | A22042A |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS CORPORATION OF THE AMERICAS |
| Manufacturer Address | 2400 RINGWOOD AVENUE SAN JOSE CA 95131 US 95131 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-08 |