MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. MINIARC PRECISE; MESH, SURGICAL, POLYMERIC

Catalog Number 720191-01

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2013

Event Type  malfunction  

Event Description

The ams mini-arc precise sling device was used and placed in the patient's obturator internus on the left and right side, but there was difficulty in releasing the trocar site.The mini arc sling device failed to disengage from the sling per the surgeon.The device was exchanged for another mini arc precise lot #792131018, ref 720191-01, 2015-09-21 exp and utilized without issue.

• Brand Name: MINIARC PRECISE
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren road west; minnetonka MN 55343
• MDR Report Key: 3631544
• MDR Text Key: 3986007
• Report Number: 3631544
• Device Sequence Number: 1
• Product Code: OTN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/25/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 720191-01
• Device Lot Number: 779686023
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/09/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2014
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 83