MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-26 for RESECTOSCOPE manufactured by Gyrus Acmi, Inc. / Olympus Surgical Technologies America.
[181422115]
Ceramic tip from resectoscope broke out during turp. Ceramic tip was retrieved without any harm to pt. Shoulder to shoulder education with the provider. The instrument was replaced with a new one in the tray. 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 is familiarized himself. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093308 |
| MDR Report Key | 9763527 |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-02-03 |
| Date Added to Maude | 2020-02-27 |
| 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 | 3 |
| Brand Name | RESECTOSCOPE |
| Generic Name | RESECTOSCOPE |
| Product Code | FJL |
| Date Received | 2020-02-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC. / OLYMPUS SURGICAL TECHNOLOGIES AMERICA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-26 |