MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-12-21 for CONMED 138030 manufactured by Conmed Electrosurgery.
[18112086]
The pt was undergoing a liver transplant. The surgeon was using a conmed abc-argon beam coagulator. The tips are disposable and the cord is good for 100 uses according to the mfr. It appears on this occasion that the metal insert which does not protrude beyond the pt end had somehow become loose inside the carrier. When the gas was applied, the metal piece was shot out with some force. The metal piece punctured the pleural space through the diaphram causing a pneumothorax and requiring a chest tube.
Patient Sequence No: 1, Text Type: D, B5
[18348326]
Conmed electrosurgery has made several attempts to contact the initial reporter. We have had no reply to our attempts to obtain the suspect device for eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1720159-2009-00048 |
| MDR Report Key | 1575149 |
| Report Source | 06 |
| Date Received | 2009-12-21 |
| Date of Report | 2009-11-25 |
| Date of Event | 2009-10-27 |
| Date Mfgr Received | 2009-11-25 |
| Date Added to Maude | 2010-01-14 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 14603 E FREMONT AVE |
| Manufacturer City | CENTENNIAL CO 80112 |
| Manufacturer Country | US |
| Manufacturer Postal | 80112 |
| Manufacturer Phone | 8005220138 |
| 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, NOZZLE |
| Product Code | HAM |
| Date Received | 2009-12-21 |
| Catalog Number | 138030 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 2009-12-21 |