MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-06-08 for HF RESECTION ELECTRODE - BUTTON WA22557C manufactured by Olympus Winter & Ibe Gmbh.
[4572466]
Olympus was informed that during a transurethral resection of the prostate (turp), the physician was shocked and the patient's leg jerked. The physician turned off the bipolar cutting and removed the device and noted that the loop had broken and was melted. The device was replaced and the procedure was successfully completed. The physician nor the patient required any treatment and the patient was sent home.
Patient Sequence No: 1, Text Type: D, B5
[12038760]
The device referenced in this report was returned to olympus for evaluation. The evaluation could not confirm the reported phenomenon of device causing a shock. It was noted that the loop was in good condition, however, the electrode was bent at the distal end and the back tip was worn out, near the connection to the teflon body. The teflon body of the electrode was unable to lock/hold the electrode due to the worn out back tip. It is believed this could be attributed to the back tip being worn out or a damaged locking mechanism inside the teflon body. Please reference associated devices reported: mfr report #: 2951238-2014-00259.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951238-2014-00258 |
| MDR Report Key | 3938797 |
| Report Source | 05,06 |
| Date Received | 2014-06-08 |
| Date of Report | 2014-05-20 |
| Date of Event | 2014-05-20 |
| Date Mfgr Received | 2014-05-20 |
| Date Added to Maude | 2014-07-30 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | HF RESECTION ELECTRODE - BUTTON |
| Generic Name | ELECTRODE |
| Product Code | FFE |
| Date Received | 2014-06-08 |
| Returned To Mfg | 2014-05-20 |
| Model Number | WA22557C |
| Catalog Number | WA22557C |
| Lot Number | 13282P031-001 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Address | KUEHNSTRASSE 61 HAMBURG 22045 GM 22045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-08 |