MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-07-19 for HF-CABLE, MONOPOLAR, 4 M, UES-30/-40, A0393 manufactured by Olympus Winter & Ibe Gmbh.
[49958964]
The device was not returned to olympus for evaluation. The cause of the reported event could not be determined; however, user handling could not be ruled out as a contributing factor. The instruction manual contains several warning statements in an effort to prevent damage to the cable. ? Visually inspect the cable and the plugs for irregularities on the surface. Do not use a cable with brittle or defective insulation. Replace the cable. In order to plug or unplug the cable always pull at the plug. Never pull at the cable.?
Patient Sequence No: 1, Text Type: N, H10
[49959085]
Olympus was informed that during a transurethral resection of the prostate (turp) procedure, the high frequency (hf) cable sparked and smoked. There was no injury to the user or patient. No emergency fire evacuation took place. The procedure was completed using a different hf cable. This is report 3 of 4.
Patient Sequence No: 1, Text Type: D, B5
[61218757]
The high frequency (hf) cable was returned to olympus for evaluation. The evaluation was unable to confirm the reported event. An olympus test working element ((b)(4)) and test generator ((b)(4)) was attached to the hf cable, and there was a consistent energy output noted at the distal end during activation. No abnormalities noted. In addition, no smoke or arcing was observed during activation. Based on the investigation findings, the root cause of the reported event could not be determined as the hf cable functioned as designed with no abnormalities.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951238-2016-00601 |
| MDR Report Key | 5802935 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-07-19 |
| Date of Report | 2016-11-14 |
| Date of Event | 2016-06-20 |
| Date Mfgr Received | 2016-10-27 |
| Date Added to Maude | 2016-07-19 |
| 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 | MR DONNY SHAPIRO |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 408935-516 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HF-CABLE, MONOPOLAR, 4 M, UES-30/-40, |
| Generic Name | HF CABLE |
| Product Code | DSA |
| Date Received | 2016-07-19 |
| Returned To Mfg | 2016-10-19 |
| Model Number | A0393 |
| Catalog Number | A0393 |
| Lot Number | 342998 |
| ID Number | 04042761001656 |
| 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 WINTER & IBE GMBH |
| Manufacturer Address | KUEHNSTRASSE 61 HAMBURG, HAMBURG US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-19 |