AUTOSUTURE LAVH KIT 178060

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-03-05 for AUTOSUTURE LAVH KIT 178060 manufactured by United States Surgical Corporation.

Event Text Entries

[1403] Patient underwent a laparscopic assisted virginal hysterectomy on 2/9/93. During surgery, the surgeon experienced a problem with the stapler in which the staples were not closing properly. Post-op the patient experienced abdominal distention, bruising, and a drop in her h/h. On 2/15 the patient was returned to surgery and an evacuation of a hematoma through the vaginal canal with 100 cc's blood evacuated. On 2/17/93, the patient was returned to the or and found to have a ureter severed from the bladder and a staple around the top of the ureter leading to the kidney. The area was irrigated, repaired and a neprostomy tube placed of 4-5 months to allow time for healing at which time a prosthetic ureter willhave to be placeddevice 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 evaluated after the event. Method of evaluation: actual device involved in incident was evaluated. Results of evaluation: invalid data. Conclusion: device failure directly contributed to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device returned to manufacturer/dealer/distributor. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2473
• MDR Report Key: 2473
• Date Received: 1993-03-05
• Date of Report: 1993-02-17
• Date of Event: 1993-02-09
• Date Facility Aware: 1993-02-17
• Report Date: 1993-02-17
• Date Reported to FDA: 1993-02-17
• Date Added to Maude: 1993-03-09
• 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: AUTOSUTURE
• Generic Name: LAVH KIT
• Product Code: FHM
• Date Received: 1993-03-05
• Model Number: LAVH KIT 178060
• Lot Number: N2H240M
• ID Number: PRODUCT # KIT-178060
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-DEC-92
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 2298
• Manufacturer: UNITED STATES SURGICAL CORPORATION

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-03-05