MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-24 for FORCE 2-20PC ELECTROSURGICAL GENERATOR N/A manufactured by Valleylab, Inc..
[1641]
Possible malfunction of unit resulting in "spark" in bladder. Ureteral orifice "cut". Ureteral catheter (stent) placement needed. Nor further complications. Device not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced:. Service provided by: user facility biomedical/bioengineering department. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, electrical tests performed, performance tests performed, visual examination. Results of evaluation: electrical problem, invalid data. Conclusion: device evaluated and alleged failure could not be duplicated, none or unknown. Certainty of device as cause of or contributor to event: maybe. Corrective actions: device returned to manufacturer/dealer/distributor. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4057 |
| MDR Report Key | 4057 |
| Date Received | 1992-07-24 |
| Date of Report | 1992-07-08 |
| Date of Event | 1992-01-21 |
| Date Facility Aware | 1992-01-31 |
| Report Date | 1992-07-08 |
| Date Reported to Mfgr | 1992-01-31 |
| Date Added to Maude | 1993-05-13 |
| 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 | FORCE 2-20PC ELECTROSURGICAL GENERATOR |
| Generic Name | ELECTROSURGICAL UNIT |
| Product Code | FAR |
| Date Received | 1992-07-24 |
| Model Number | FORCE 2-20PC |
| Catalog Number | N/A |
| Lot Number | N/A |
| ID Number | N/A |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Age | 01-JAN-89 |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 3790 |
| Manufacturer | VALLEYLAB, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-07-24 |