MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-02-23 for MONOPOLAR CABLE, ELECTROSURGICAL ACCESSORIES 600-290 * manufactured by Bowa Electronic Zubehor Fur Electrochiru.
[392533]
The surgeon reported the cable is broken. No further information is available at this time. Additional information was received in september 2004 from the reporter. The customer reported that the monopolar cable had broken. No patient injury was reported. The cautery cord separated from the connector. There was an appearance of static on the screen before hand. When the surgeon started using the monopolar device, the cord was fine then the cord snapped in half. No patient injury or user injury was reported. There is a potential for an electrical shock to the user when disconnecting cord from the power supply. A spark or fire in an operating room has the potential to cause a serious injury such as a burn. In order to insure pt safety aorn standards recommend that during laparoscopic procedures one should: examine all electrodes for impaired insulation before use, ensure proper connection or equipment, ensure that the active electrode is not activated until it is in close proximity to the tissue, and use the lowest power setting that achieves the desired result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2430952-2005-00010 |
| MDR Report Key | 575555 |
| Date Received | 2005-02-23 |
| Date of Report | 2004-02-23 |
| Date Facility Aware | 2004-09-07 |
| Report Date | 2005-02-23 |
| Date Reported to FDA | 2005-02-23 |
| Date Reported to Mfgr | 2005-02-23 |
| Date Added to Maude | 2005-02-25 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MONOPOLAR CABLE, ELECTROSURGICAL ACCESSORIES |
| Generic Name | ENDOSCOPIC INSTRUMENT |
| Product Code | FFZ |
| Date Received | 2005-02-23 |
| Model Number | 600-290 |
| Catalog Number | * |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 565406 |
| Manufacturer | BOWA ELECTRONIC ZUBEHOR FUR ELECTROCHIRU |
| Manufacturer Address | * GOMARINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-02-23 |