MAUDE Adverse Event Report: AMS RETROARC SLING SYSTEM; BLADDER SLING

Catalog Number 9000262

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2016

Event Type  malfunction  

Event Description

During procedure, needle wouldn't lock into handle.No patient harm.

• Brand Name: RETROARC SLING SYSTEM
• Type of Device: BLADDER SLING
• Manufacturer (Section D): AMS; eden prairie MN 55347
• MDR Report Key: 5412405
• MDR Text Key: 37617407
• Report Number: MW5060020
• Device Sequence Number: 1
• Product Code: OTP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9000262
• Device Lot Number: 949732047
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/02/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 92