MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-25 for RESECTOSCOPE manufactured by Gyrus Medical Ltd. / Olympus Winter & Ibe Gmbh.
[181157964]
During the transurethral resection of bladder tumor, the ceramic tip of the resectoscope was broken. The broken pieces were retrieved and thrown away prior to reporting the incident. The instrument was replaced in the tray by sps. Discussed the case with operating room mgr, surgeon and contacted the company rep. Surgeon mentioned that he is unfamiliar with a particular aspect of this resectoscope. We contacted the company to educate the surgeon and be there for next couple of cases until the surgeon familiarizes himself.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093261 |
| MDR Report Key | 9753187 |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-01-06 |
| Date Added to Maude | 2020-02-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| 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 | RESECTOSCOPE |
| Generic Name | COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES) |
| Product Code | HFG |
| Date Received | 2020-02-25 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS MEDICAL LTD. / OLYMPUS WINTER & IBE GMBH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-25 |