MULTIFIRE ENDO GIA 30 030813 SIZE 3.5

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-06 for MULTIFIRE ENDO GIA 30 030813 SIZE 3.5 manufactured by United States Surgical Corporation/auto Suture.

Event Text Entries

[990] Patient underwent (3/13/92) a laparoscopy, lysis of adhesions, and left salpingo oophorectomy. The autosuture was used during procedure and was felt to have functioned as designed. Device disposed of at end of case. Following usuage, "pelvis was irrigated... Area was hemostatic. " patientr was transferred to recovery area, patient observed fopr approximately two hours then discharged to home. Readmitted twenty-two hours later with intra abdominal bleed;transfused with two units packed cells on 3/14/92. Bleeding was noted coming from the middle of the site where the autosuture was used. Two other areas near the bladder were noted to have slight oozingdevice 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 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: yes. Corrective actions: device discarded. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3200
• MDR Report Key: 3200
• Date Received: 1992-07-06
• Date of Report: 1992-03-24
• Date of Event: 1992-03-13
• Date Facility Aware: 1992-03-14
• Report Date: 1992-03-24
• Date Reported to Mfgr: 1992-03-24
• Date Added to Maude: 1993-04-12
• 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: MULTIFIRE ENDO GIA 30
• Generic Name: DISPOSABLE SURGICAL STAPLER
• Product Code: GAG
• Date Received: 1992-07-06
• Model Number: 030813 SIZE 3.5
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 2985
• Manufacturer: UNITED STATES SURGICAL CORPORATION/AUTO SUTURE

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-07-06