MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2014-09-05 for OLYMPUS HF RESECTION ELECTRODES A22206C manufactured by Olympus Winter & Ibe Gmbh.
[21724461]
Olympus was informed that during a transurethral resection of the prostate (turp) procedure, the loop on the device broke off inside the pt. The procedure was completed with a second electrode. No additional info was provided.
Patient Sequence No: 1, Text Type: D, B5
[22144616]
This supplemental report is being submitted to provide additional info based on the eval of the device. The eval confirmed that the electrode was damaged and broken. It was noted that the loop wire had broken off at both sides of the red filter section, and there was evidence of thermal damage and melting at the damaged areas. The device has been forwarded to the original equipment mfr for further investigation. If additional info is available at a later time, this report will be supplemented accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951238-2014-00422 |
| MDR Report Key | 4098928 |
| Report Source | 01,06,07 |
| Date Received | 2014-09-05 |
| Date of Report | 2014-05-23 |
| Date of Event | 2014-05-01 |
| Date Mfgr Received | 2014-05-23 |
| Date Added to Maude | 2014-09-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | NOEMI SCHAMBACH |
| Manufacturer Street | 2400 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355002 |
| Manufacturer G1 | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Street | KUEHNSTRASSE 61 |
| Manufacturer City | HAMBURG 22045 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 22045 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS HF RESECTION ELECTRODES |
| Generic Name | RESECTION ELECTRODES |
| Product Code | FDC |
| Date Received | 2014-09-05 |
| Returned To Mfg | 2014-07-16 |
| Model Number | A22206C |
| Catalog Number | A22206C |
| Lot Number | 13282P02L001 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Address | KUEHNSTRASSE 61 HANBURG 22045 GM 22045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-05 |