MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,06 report with the FDA on 2007-08-30 for CONMED 60-6900-001 manufactured by Conmed Electrosurgery.
[18840862]
Per the biomed (b)(6), he stated that during surgery this morning a female pt developed a burn at the right corner of her mouth where the lips meet from a pin hole breach that the surgeon feels developed in the suction coagulator during surgery - this item had been checked out before the surgery and no defects were discovered at that time. The pt was having her tonsils and adenoids removed. Plastic surgeons were called in after the burn was discovered. The pt received stitches at the burn site and was moved to recovery. Per the operating room manager, the pt is doing very well.
Patient Sequence No: 1, Text Type: D, B5
[19120867]
The returned device was evaluated and confirmed to have an energy breach. The damage done to the device makes it difficult to impossible to determine the root cause of this event. Additional devices of the same part number, and lot number close to suspect device's lot number were tested. These additional tests revealed no failures. This device is bend-able. It may be possible that the user used some sort of device/tool to bend the product, possibly compromising the insulation. The user facility cannot confirm this. Any additional info obtained through our investigations will be forwarded to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1720159-2007-00037 |
| MDR Report Key | 2181936 |
| Report Source | 04,06 |
| Date Received | 2007-08-30 |
| Date of Report | 2007-08-29 |
| Date of Event | 2007-08-07 |
| Date Mfgr Received | 2007-08-29 |
| Date Added to Maude | 2011-08-01 |
| 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 E. FREMONT AVE. |
| 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 | 2007-08-30 |
| Returned To Mfg | 2007-08-09 |
| Model Number | 60-6900-001 |
| Lot Number | 07AHL003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED ELECTROSURGERY |
| Manufacturer Address | CENTENNIAL CO 80112 US 80112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2007-08-30 |