MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-04-13 for LAPAROSCOPIC EQUIPMENT ME 2093.00/5119.00 (ESU) manufactured by Richard Wolf Medical Instruments Corp..
[15011192]
Pt scheduled for laparoscopic cholecystectomy. Surgeon attempted laparoscopic cholecystectomy, proceeded to open cholecystectomy. 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: 01-feb-93. Service provided by: invalid data. Service records available. 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. Results of evaluation: invalid data. Conclusion: user error caused event, other. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device discarded. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8042 |
| MDR Report Key | 8042 |
| Date Received | 1994-04-13 |
| Date of Report | 1994-04-07 |
| Report Date | 1994-04-07 |
| Date Reported to FDA | 1994-04-07 |
| Date Added to Maude | 1994-06-21 |
| 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 | LAPAROSCOPIC EQUIPMENT |
| Generic Name | LAPAROSCOPIC EQUIPMENT |
| Product Code | KOA |
| Date Received | 1994-04-13 |
| Model Number | ME 2093.00/5119.00 (ESU) |
| Catalog Number | ME 2093.00/5119.00 (ESU) |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Age | 01-NOV-90 |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 7717 |
| Manufacturer | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-04-13 |