MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-04 for ENDOPATH TROCAR SHEATH TS111 manufactured by Ethicon.
[8024]
Tip of sheath broke off inside of patient's abdomen during laparoscopic tubal ligation. X-ray taken in o. R. Laparostomy performed and tip found and removed. Device 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. Service records not available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: visual examination. Results of evaluation: component failure. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9860 |
| MDR Report Key | 9860 |
| Date Received | 1994-02-04 |
| Date of Report | 1993-08-20 |
| Date of Event | 1993-08-20 |
| Date Facility Aware | 1993-08-20 |
| Report Date | 1993-08-20 |
| Date Reported to Mfgr | 1993-08-20 |
| Date Added to Maude | 1995-02-02 |
| 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 TROCAR SHEATH |
| Product Code | FBQ |
| Date Received | 1994-02-04 |
| Model Number | TS111 |
| Lot Number | EE5671 |
| Device Expiration Date | 1998-01-01 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 9512 |
| Manufacturer | ETHICON |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-02-04 |