MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-06 for ENDOPATH DISPOSABLE SURGICAL TROCAR W/RADIOLUCENT SLEEVE R1011 manufactured by Ethicon.
[2396]
Laporoscopic cholecystectomy planned. Patient had many adhesions due to previous surgeries. Upon entry, trocar perforated sigmoid colon. Treatment included surgical repair to the colon and prophylactic antibiotic coveragedevice labeled for single use. 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. No imminent hazard to public health claimed. Device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: none or unknown, other. Results of evaluation: inherent risk of procedure, patient's condition - predisposed event. Conclusion: device discarded - unable to follow-up, there was no device failure. Certainty of device as cause of or contributor to event: no. Corrective actions: none or unknown. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3199 |
| MDR Report Key | 3199 |
| Date Received | 1992-07-06 |
| Date of Report | 1992-01-31 |
| Date of Event | 1992-01-27 |
| Date Facility Aware | 1992-01-27 |
| Report Date | 1992-01-31 |
| Date Reported to Mfgr | 1992-01-31 |
| Date Added to Maude | 1993-04-12 |
| 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 W/RADIOLUCENT SLEEVE |
| Generic Name | 10/11 TROCAR |
| Product Code | FBQ |
| Date Received | 1992-07-06 |
| Model Number | R1011 |
| Catalog Number | R1011 |
| Lot Number | N/A |
| ID Number | U.S. PATENT 4535773 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 2984 |
| Manufacturer | ETHICON |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-07-06 |