MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-07-14 for MONOPOLAR CABLE, ELECTROSURGICAL ACCESSORIES * 600-290 manufactured by Bowa-electronic.
[19158013]
The customer states that while the cautery cord was attached to the scissor and in use by the physician the cord at the end of the scissor broke and sparked. The cord was immediately removed from the field. No injury occurred to the pt or the staff in the operating room.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2430952-2006-00030 |
| MDR Report Key | 740048 |
| Date Received | 2006-07-14 |
| Date of Report | 2006-07-13 |
| Date Facility Aware | 2006-06-07 |
| Report Date | 2006-07-13 |
| Date Added to Maude | 2006-07-27 |
| 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 | JARIT ENDOSCOPIC INSTRUMENT |
| Product Code | FFY |
| Date Received | 2006-07-14 |
| Returned To Mfg | 2006-06-09 |
| Model Number | * |
| Catalog Number | 600-290 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOWA-ELECTRONIC |
| Manufacturer Address | * GOMARINGEN GM |
| Baseline Brand Name | MONOPOLAR CABLE FOR ENDOSCOPIC INSTRUMENTS |
| Baseline Generic Name | JARIT ENDOSCOPIC INSTRUMENT |
| Baseline Model No | * |
| Baseline Catalog No | 701-001 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-07-14 |