AUTO SUTURE MULTI FIRE ENDO GIA 30 030813

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-08-15 for AUTO SUTURE MULTI FIRE ENDO GIA 30 030813 manufactured by United States Surgical Corp..

Event Text Entries

[6830] During a laparscopic procedure, the stapler cartridge and blade became disconnected drom main unit. The cartridge and a staple remained connected to a ligament; the blade was loose in the peritoneal cavity. With great effort the blade and cartridge were removed. The remaining staple half necessitated a laparotomy for removal. The stapler unit was being used in connection with a trocar, believed to have been a u. S. S. C. Disposable but n/a per reg. Sales rep. 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. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: mechanical problem, telemetry failure, inherent risk of procedure, unanticipated short term complication of procedure, connector or adaptor, other. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 8673
• MDR Report Key: 8673
• Date Received: 1994-08-15
• Date of Report: 1994-06-10
• Date of Event: 1994-05-21
• Date Facility Aware: 1994-05-21
• Report Date: 1994-06-10
• Date Reported to FDA: 1994-06-10
• Date Reported to Mfgr: 1994-06-10
• Date Added to Maude: 1994-10-17
• 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: AUTO SUTURE MULTI FIRE ENDO GIA 30
• Generic Name: DISPOSABLE STAPLER
• Product Code: HBS
• Date Received: 1994-08-15
• Model Number: 030813
• Catalog Number: 030813
• Lot Number: N3073 (PER JEFF MILLER)
• Device Expiration Date: 1998-05-01
• Device Availability: Y
• Device Age: 01-MAY-93
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 8337
• Manufacturer: UNITED STATES SURGICAL CORP.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1994-08-15