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

Model Number	IPN921000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/17/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3011137372-2022-00208
• Device Sequence Number: 20497354
• Product Code: FZP
• UDI-Device Identifier: 14026704737434
• UDI-Public: 14026704737434
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2022

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2022
• Supplement Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown