MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2010-07-14 for CONMED 130321 manufactured by Conmed Electrosurgery.
[1593166]
Conmed electrosurgery received one abc triple option handpiece for evaluation. During our evaluation, the suspect device self activated.
Patient Sequence No: 1, Text Type: D, B5
[8615104]
Our investigation team found the coag button to self activate when plugged into the esu during testing. We dissected the handpiece and found no irregularities. Our evaluation continued by stripping the supply wire/cable to perform continuity testing. It was observed, the red wire and the black wire of the supply wire/cable to be shorted causing the self activation. The reported malfunction was confirmed. Manufacturing facility was made aware regarding this complaint. Our manufacturing facility was made aware of this confirmed event. A device history record review was performed which revealed no nonconformances.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1720159-2010-00048 |
| MDR Report Key | 1760672 |
| Report Source | 00 |
| Date Received | 2010-07-14 |
| Date of Report | 2010-07-13 |
| Date of Event | 2010-05-28 |
| Date Mfgr Received | 2010-05-28 |
| Device Manufacturer Date | 2009-08-01 |
| Date Added to Maude | 2011-03-07 |
| 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 Street | 14603 EAST FREMONT AVE. |
| Manufacturer City | CENTENNIAL CO 80112 |
| Manufacturer Country | US |
| Manufacturer Postal | 80112 |
| Manufacturer Phone | 8005520138 |
| Manufacturer G1 | CONMED ELECTROSURGERY |
| 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 | ARGON BEAM COAGULATION HANDPIECE |
| Product Code | HAM |
| Date Received | 2010-07-14 |
| Returned To Mfg | 2010-05-11 |
| Catalog Number | 130321 |
| Lot Number | 0908133 |
| Operator | OTHER |
| 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 | 2010-07-14 |