MAUDE Adverse Event Report: TELEFLEX MEDICAL VLOCK ML CLIP 6/CART 14/BOX; CLIP, IMPLANTABLE

Model Number IPN921000

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/17/2022

Event Type  Injury  

Event Description

It was reported that a ml vesolock clip broke during a robotic laparoscopy cholecystomy case.Additional information: it is unknown if any part of the broken clip fell inside the patient; noting was found.The clip was being applied to a vessel when it broke and there was no reported vessel damage.

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that a ml vesolock clip broke during a robotic laparoscopy coecostomy case.Additional information: it is unknown if any part of the broken clip fell inside the patient; noting was found.The clip was being applied to a vessel when it broke and there was no reported vessel damage.

• Brand Name: VLOCK ML CLIP 6/CART 14/BOX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15775193
• MDR Text Key: 303541982
• Report Number: 3011137372-2022-00208
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 14026704737434
• UDI-Public: 14026704737434
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152082
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN921000
• Device Catalogue Number: 51114V
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED