MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,health professional,use report with the FDA on 2015-04-03 for WORKING ELEMENT RESECTOSCOPE WA22367A manufactured by Olympus America & Ibe Gmbh.
[5610367]
Olympus was informed that during an transurethral resection of the prostrate (turp) procedure, the physicians glove caught fire while using an electrosurgical unit (esu) and working element. However, it was reported that there was no patient injury. Olympus followed up with the user facility and was informed that the physician did not require any medical or surgical treatment and sustained no injury. The intended procedure was completed with another similar device. The esu, working element and hf cable will be returned to olympus for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[13276887]
The device referenced in this report has not yet been returned to olympus for evaluation. The exact cause of the event could not be conclusively determined at this time. If additional information becomes available at a later time, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[26251764]
This supplemental report is being submitted as the device was returned to olympus for evaluation. The device was attached to test equipment and it was found that the electrode passage was functional and the reported phenomenon could not be confirmed. In addition, the device was checked with a test electrosurgical generator and the power output was able to be generated without any issues. The device also passed the dielectric test. A visual inspection found minor rust (corrosion) on the bottom of the hf port due to evidence of fluid invasion, which most likely caused the reported phenomenon. When the hf port was removed, brown stains (corrosion) was noted inside the teflon body. However, there was no indication of spark discharge or charring residues inside the teflon body when inspected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951238-2015-00168 |
| MDR Report Key | 4666626 |
| Report Source | 05,06,HEALTH PROFESSIONAL,USE |
| Date Received | 2015-04-03 |
| Date of Report | 2015-09-18 |
| Date of Event | 2015-03-18 |
| Date Mfgr Received | 2015-06-18 |
| Date Added to Maude | 2015-05-18 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | NOEMI SCHAMBACH |
| Manufacturer Street | 2400 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE CA 951311700 |
| Manufacturer Country | US |
| Manufacturer Postal | 951311700 |
| Manufacturer Phone | 4089355002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WORKING ELEMENT RESECTOSCOPE |
| Product Code | FDC |
| Date Received | 2015-04-03 |
| Returned To Mfg | 2015-06-15 |
| Model Number | WA22367A |
| Catalog Number | WA22367A |
| Lot Number | 101W-019 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS AMERICA & IBE GMBH |
| Manufacturer Address | KUEHNSTRASSE 61 22045 GM 22045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-03 |