FDA Adverse Event Malfunction Summary report: N

ENDO STITCH

MDR report key: 251206 · Received November 22, 1999

Report

Report Number
MW1017615
Event Type
Malfunction
Date Received
November 22, 1999
Date of Event
September 30, 1999
Report Date
November 22, 1999
Manufacturer
UNITED STATES SURGICAL CORP.
Product Code
MFJ
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CO, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

DURING LAPAROSCOPIC MYOMECTOMY, HTE ENDOSTITCH NEEDLE BROKE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ENDO STITCH ENDO STITCH SUTURE DEVICE MFJ UNITED STATES SURGICAL CORP. UNK *

Patients

Seq Age Sex Outcome Treatment
1 42 YR Other