MAUDE Adverse Event Report: BOSTON SCIENTIFIC UPHOLD LITE

Model Number M0068318170

Device Problems Bent (1059); Defective Device (2588)

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

Event Date 02/03/2015

Event Type  malfunction  

Event Description

During vaginal vault suspension surgery, two boston scientific uphold lite carriers were defective.Both bent and would not return to the center of the catch.Mesh was used but not the carrier.When opened second device, and noticed carrier was again bent so it was not used.

• Brand Name: UPHOLD LITE
• Type of Device: UPHOLD LITE
• Manufacturer (Section D): BOSTON SCIENTIFIC; marlbourgh 01752
• MDR Report Key: 4540737
• MDR Text Key: 20014059
• Report Number: MW5040829
• Device Sequence Number: 2
• Product Code: OTP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/18/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M0068318170
• Device Lot Number: ML0000265
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/18/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 59