MAUDE Adverse Event Report: VECTEC TLIFT®; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number AW16280

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 09/06/2018

Event Type  malfunction  

Event Description

T-lifts were used to retract the bilateral ovaries.The t lifts were watched and noted to be removed intact as they passed through the trocars, however on final count an ~ 2cm portion of the plastic arm was noted to be missing.Staff unable to locate this portion of plastic and it was not radiopaque not allowing for identification by imaging.Pt was notified of this event.

• Brand Name: TLIFT®
• Type of Device: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• Manufacturer (Section D): VECTEC; 151 walt whitman ave.; newport news VA 23606
• MDR Report Key: 7925622
• MDR Text Key: 122344938
• Report Number: 7925622
• Device Sequence Number: 1
• Product Code: NWV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AW16280
• Device Catalogue Number: AW16280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/25/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/02/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 12045 DA