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 2016-08-05 for HF-CABLE, MONOPOLAR, 4 M, UES-30/-40, A0393 manufactured by Olympus Winter & Ibe Gmbh.
[51292894]
The device was returned to olympus for evaluation. The evaluation was unable to confirm the reported device malfunction. Olympus was unable to test the device as the device was received broken apart below the connector plug; however, there were no signs of burn or charred marks found with the device. The root cause for the reported event is most likely due to excessive stress and force caused by user handling. 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 or risk of damaging the cable may occur.?
Patient Sequence No: 1, Text Type: N, H10
[51292895]
Olympus was informed that during a therapeutic transurethral resection of the prostate (turp) procedure, the device sparked/smoked when the physician was performing the cut function during the resection of the bladder. No emergency fire evacuation occurred as a result of the reported event. There was no patient or user injury reported. The procedure was completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2016-00648 |
| MDR Report Key | 5850724 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-08-05 |
| Date of Report | 2016-08-05 |
| Date of Event | 2016-05-12 |
| Date Mfgr Received | 2016-07-20 |
| Date Added to Maude | 2016-08-05 |
| 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 | 2016-08-05 |
| Returned To Mfg | 2016-07-20 |
| Model Number | A0393 |
| Catalog Number | A0393 |
| Lot Number | 342998 |
| ID Number | 04042761001656 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 22045 GM 22045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-05 |