MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-09 for ENDOPATH TRISTAR SURGICAL TROCAR TS111 manufactured by Ethicon Endo-surgery - Ethicon, Inc..
[7890]
Patient was taken to or for endoscopic cholecystectomy, possible open cholecystectomy. During the second puncture with the surgical trocar, a piece of the sheath broke off and fell into the periteneum cavity. Procedure was converted to an open procedure to retreive the piece in addition to the fact that the patient had many adhesions which would have necessitated converting to an open procedure. Entire piece was retreived. Patient did well after surgery. Surgical time was not extended.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 10141 |
| MDR Report Key | 10141 |
| Date Received | 1993-08-09 |
| Date of Report | 1993-07-14 |
| Date of Event | 1993-07-06 |
| Date Facility Aware | 1993-07-06 |
| Report Date | 1993-07-14 |
| Date Reported to FDA | 1993-07-15 |
| Date Reported to Mfgr | 1993-07-15 |
| Date Added to Maude | 1993-09-20 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOPATH TRISTAR SURGICAL TROCAR |
| Generic Name | SURGICAL TROCAR |
| Product Code | FBQ |
| Date Received | 1993-08-09 |
| Model Number | TS111 |
| ID Number | EE 8639 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 10141 |
| Manufacturer | ETHICON ENDO-SURGERY - ETHICON, INC. |
| Manufacturer Address | CINCINNATI OH 452422839 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-08-09 |