ENDOPATH DISPOSABLE SURGICAL TROCAR AND SLEEVE R1011

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-27 for ENDOPATH DISPOSABLE SURGICAL TROCAR AND SLEEVE R1011 manufactured by Ethicon, Inc..

Event Text Entries

[17254019] Following insertion of the initial trocar during a laparoscopic cholecystectomy it was discovered that the aorta and small bowel had been perforated. The surgery was immediately changed to a laparotomy with repair of the aorta, repair of the small bowel, and an open cholecystectomy. The patient is expected to make a full recovery. The device is being held for both an independent and manufacturer evaluation because of a question of device malfunction/failure of the safety shield. 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. Invalid data - service records availability. No imminent hazard to public health claimed. Invalid data - whether device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: maybe. Corrective actions: other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 7656
• MDR Report Key: 7656
• Date Received: 1994-01-27
• Date of Report: 1993-08-03
• Date of Event: 1993-07-22
• Date Facility Aware: 1993-07-22
• Report Date: 1993-08-03
• Date Reported to Mfgr: 1993-07-23
• Date Added to Maude: 1994-05-06
• 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

Device Details

• Brand Name: ENDOPATH DISPOSABLE SURGICAL TROCAR AND SLEEVE
• Product Code: FBQ
• Date Received: 1994-01-27
• Model Number: R1011
• Device Availability: Y
• Device Age: 01-OCT-92
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 7335
• Manufacturer: ETHICON, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1994-01-27