MAUDE Adverse Event Report: COOPERSURGICAL FILSHIE TUBAL LIGATION SYSTEM

Model Number AVM-851

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/29/2014

Event Type  malfunction  

Event Description

Tubal clip was defective.Dates of use: (b)(6) 2014.Diagnosis or reason for use: tubal ligation.

• Brand Name: FILSHIE TUBAL LIGATION SYSTEM
• Type of Device: LIGATION SYSTEM
• Manufacturer (Section D): COOPERSURGICAL; romsey
• MDR Report Key: 4024761
• MDR Text Key: 18569375
• Report Number: MW5037758
• Device Sequence Number: 1
• Product Code: KNH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2016
• Device Model Number: AVM-851
• Device Lot Number: 33745
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 38 YR