MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,06 report with the FDA on 2007-08-15 for CONMED 60-6900-001 manufactured by Conmed Electrosurgery.
[21344460]
Conmed electrosurgery received a suction coagulator. Esu interface was performed, the device was tested in all modes and the returned foot controlled suction coagulator passed, it operated as expected. There was no damage or breakdown with the insulation. During the esu interface the returned foot control suction coagulator under test sparked only at the tip of the tube; this is expected as designed. The reported malfunction was not confirmed.
Patient Sequence No: 1, Text Type: N, H10
[21591499]
Burn just outside the right corner of the patient's mouth during a tonsillectomy. Dr. Seemed to think the burn was caused by insulation failure, because the suction coagulator often rests alongside that part of the anatomy during this type of procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1720159-2007-00038 |
| MDR Report Key | 898064 |
| Report Source | 04,06 |
| Date Received | 2007-08-15 |
| Date of Report | 2007-08-13 |
| Date of Event | 2007-07-18 |
| Date Mfgr Received | 2007-07-19 |
| Date Added to Maude | 2007-08-20 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JEFF DICKINSON |
| Manufacturer Street | 14603 EAST FREMONT AVENUE |
| Manufacturer City | CENTENNIAL CO 80112 |
| Manufacturer Country | US |
| Manufacturer Postal | 80112 |
| Manufacturer Phone | 8005520138 |
| Manufacturer Street | 7211 SOUTH EAGLE ST. |
| Manufacturer City | CENTENNIAL CO 80112 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80112 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONMED |
| Generic Name | SUCTION COAGULATOR |
| Product Code | FEH |
| Date Received | 2007-08-15 |
| Returned To Mfg | 2007-07-26 |
| Model Number | 60-6900-001 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 874599 |
| Manufacturer | CONMED ELECTROSURGERY |
| Manufacturer Address | CENTENNIAL CO 80112 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-08-15 |