MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-01-05 for ENDOPATH DISPOSABLE SURGICAL TROCAR R-0005 manufactured by Ethicon, Inc..
[2033]
On july 1, 1992, a patient underwent a laparoscopic cholecystectomy. During insertion of the ethicon 5mm disposable trocar the protective sheath did not come down over the trocar and the liver was punctured but otherwise was not significant. The patinet had no complications from this incidentinvalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding 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. No imminent hazard to public health claimed. 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: yes. Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2732 |
| MDR Report Key | 2732 |
| Date Received | 1993-01-05 |
| Date of Report | 1993-01-01 |
| Date of Event | 1992-07-01 |
| Date Facility Aware | 1992-07-01 |
| Report Date | 1993-01-01 |
| Date Reported to Mfgr | 1993-01-01 |
| Date Added to Maude | 1993-03-24 |
| 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 | ENDOPATH DISPOSABLE SURGICAL TROCAR |
| Generic Name | SURGICAL TROCAR |
| Product Code | FBQ |
| Date Received | 1993-01-05 |
| Model Number | R-0005 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | * |
| Implant Flag | * |
| Device Sequence No | 1 |
| Device Event Key | 2548 |
| Manufacturer | ETHICON, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-01-05 |