TROCAR DDF-0922

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-01-15 for TROCAR DDF-0922 manufactured by Ethicon Endosurgery.

Event Text Entries

[2825] Patient was to undergo an exploratory laproscopic procedure. It is assumed that during the placement of the trocar, the device punctured the bowel and the common iliac artery. The injuries required the patient's abdomen to be opened and the puncture wounds of the bowel closed with sutures and reanastomosis of the arteryinvalid 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. 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: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4376
• MDR Report Key: 4376
• Date Received: 1993-01-15
• Date of Report: 1993-01-15
• Report Date: 1993-01-15
• Date Added to Maude: 1993-05-21
• 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: TROCAR
• Product Code: FBQ
• Date Received: 1993-01-15
• Model Number: DDF-0922
• Lot Number: DH32KI
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: *
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 4101
• Manufacturer: ETHICON ENDOSURGERY

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-01-15