MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-29 for MONOPOLAR CORD CABLE GK246 manufactured by Aesculap.
[63557158]
Patient Sequence No: 1, Text Type: N, H10
[63557159]
The surgeon was using a bugbee monopolar instrument that was attached to the bovie machine with a cable. During use, the tip of the cord that was attached to the bovie machine sparked and the cord broke into 2 pieces. A second cord was opened and the vessel was sealed off without problems.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6213530 |
| MDR Report Key | 6213530 |
| Date Received | 2016-12-29 |
| Date of Report | 2016-12-05 |
| Date of Event | 2016-11-17 |
| Report Date | 2016-12-05 |
| Date Reported to FDA | 2016-12-05 |
| Date Reported to Mfgr | 2016-12-05 |
| Date Added to Maude | 2016-12-29 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MONOPOLAR CORD CABLE |
| Generic Name | CORD, ELECTRIC, FOR ENDOSCOPE |
| Product Code | FFZ |
| Date Received | 2016-12-29 |
| Model Number | GK246 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP |
| Manufacturer Address | 3773 CORPORATE PKWY. CENTER VALLEY PA 18034 US 18034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-29 |