MAUDE Adverse Event Report: VECTEC VECTEC T LIFT

Lot Number B163190

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/27/2018

Event Type  malfunction  

Event Description

During procedure, a small piece of plastic t lift broke off into the patient's abdomen.After checking, the md found and removed the object.Diagnosis or reason for use: lap sacrocolpopexy.

• Brand Name: VECTEC T LIFT
• Type of Device: VECTEC T LIFT
• Manufacturer (Section D): VECTEC
• MDR Report Key: 7365747
• MDR Text Key: 103519871
• Report Number: MW5076029
• Device Sequence Number: 1
• Product Code: NWV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2018

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: No Information
• Device Expiration Date: 11/30/2018
• Device Lot Number: B163190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1