MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-12-29 for ARGON BEAM COAGULAR - PROBE 160655 manufactured by Birtcher Medical Systems.
[2156]
During surgical procedure for endometrosis, argon coagulator ceased to function for a short period of time; bladder burn later discovered and sutured. Unit was being demonstrated for possible purchaseinvalid data - regarding single use labeling of device. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device permanently removed from service, other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3597 |
| MDR Report Key | 3597 |
| Date Received | 1992-12-29 |
| Date of Report | 1992-12-07 |
| Date of Event | 1992-11-20 |
| Date Facility Aware | 1992-11-20 |
| Report Date | 1992-12-07 |
| Date Reported to Mfgr | 1992-12-07 |
| Date Added to Maude | 1993-04-26 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARGON BEAM COAGULAR - PROBE |
| Generic Name | PROBE |
| Product Code | HQB |
| Date Received | 1992-12-29 |
| Catalog Number | 160655 |
| Lot Number | 6-0280-001 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | * |
| Device Sequence No | 1 |
| Device Event Key | 3337 |
| Manufacturer | BIRTCHER MEDICAL SYSTEMS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. No Informationnvalid Deathata | 1992-12-29 |