MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2015-03-20 for OLYMPUS WORKIGN ELEMENT, PASSIVE WA22067A manufactured by Olympus Winter & Ibe Gmbh.
[5678290]
Olympus was informed that during an unknown procedure, the electrode arced and caught fire when the wire was put through the device. No additional information was provided. Olympus followed up with the user facility and it was reported that this was an isolated event and that there was no patient injury reported. The reported event occurred toward the end of the procedure, when the physician was using coag function with a vaportrode device, the device arced and a brief spark was observed. It was noted that there was a burnt mark around the release button. However, there were no flames observed or smoke coming from the device. The connection were checked and found okay. There were no other devices replaced and the intended procedure was completed.
Patient Sequence No: 1, Text Type: D, B5
[13093969]
The device referenced in this report was returned to olympus for evaluation. The evaluation confirmed the reported phenomenon of a damaged electrode. However, the evaluation was unable to determine the root cause of the broken tip, as the missing portion was not returned. A visual inspection found the electrode release button missing with black stains inside the button hole. A test electrode was used during testing to check the electrode passage and found the device working element could not lock/secure the test electrode ito position due to a damaged locking pin inside the teflon body. The high frequency (hf) connector was removed and mor charred residues was found inside the teflon body. A broken tip of the returned electrode proximal end was found stuck inside the hf connector base upon inspection. The most likely cause of the reported phenomenon is due to the damaged electrode release button could not hold the electrode properly. When the hf current was activated, a spark discharged and caused damage to the teflon body. The device was serviced and returned to the user facility.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951238-2015-00106 |
| MDR Report Key | 4645327 |
| Report Source | 06,07 |
| Date Received | 2015-03-20 |
| Date of Report | 2015-03-06 |
| Date of Event | 2015-03-06 |
| Date Mfgr Received | 2015-03-06 |
| Date Added to Maude | 2015-05-13 |
| 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 SCHAMBACK |
| Manufacturer Street | 2400 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS WORKIGN ELEMENT, PASSIVE |
| Generic Name | HF-WORKING ELEMENT, RESECTOSCOPE |
| Product Code | FDC |
| Date Received | 2015-03-20 |
| Returned To Mfg | 2015-03-11 |
| Model Number | WA22067A |
| Catalog Number | WA22067A |
| Lot Number | 121W-0059 |
| 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 | 2015-03-20 |