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

Model Number	IPN055290
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Intra-Abdominal Hemorrhage (4479)
Date of Event	10/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Reported issue: lap chole went normal, no issues occluding vessels and dividing.Post op patient came back with blood in the abdomen.Surgeon coud not be 100% sure it was the cystic artery but believes that is where the bleeding came from the clip breaking/falling off.Believes the vesolok is more brittle and does not have the same tactile closure as hemolok.The patient's condition was reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one unopened representative sample of 51114v vlock ml clip 6/cart 14/box for investigation.No broken clip or clip applier was returned.The returned sample was visually examined with and without magnification.No defects or anomalies were observed.Functional inspection was performed on the returned clips.A lab inventory clip applier was used.All clips were able to properly load into the jaws of the applier and were successfully applied to over-stressed surgical tubing without detaching.It is possible that the reported issue was caused by using damaged/misaligned appliers, but this could not be confirmed since the appliers were not returned for investigation.No functional issues were found with the returned clips.The finished goods dhr was reviewed.Per the dhr, lot number: 228044 of product 51114v vlock ml clip 6/cart 14/box was manufactured on 16mar2022.A total of (b)(4) units were manufactured.The lot was released on 08apr2022.Dhr investigation did not show issues related to complaint.The ifu for this product, 15-lb-00287 rev.00, was reviewed as a part of this complaint investigation.The ifu states, "manual-load applier/remover jaws are delicate and can easily become damaged, as can some other applier/remover components.Mishandling of applier/removers may result in improper load and/or closure of the jaws.Appropriate care, cleaning, lubrication and maintenance are important to ensure proper function.Please examine the applier/remover before each surgery for potential damage." a corrective action is not required at this time as there were no functional issues found with the returned representative sample.The reported complaint of "broken/detached parts - clip - hinge" could not be confirmed.One representative cartridge was returned.Upon functional inspection, the clips could be loaded into the jaws of a lab inventory applier and were able to properly close onto over-stressed surgical tubing with no issues.A dhr review was performed with no evidence to suggest a manufacturing related issue.Since there were no functional issues with the returned clips, the complaint cannot be confirmed.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
Reported issue: lap chole went normal, no issues occluding vessels and dividing.Post op patient came back with blood in the abdomen.Surgeon could not be 100% sure it was the cystic artery but believes that is where the bleeding came from the clip breaking/falling off.Believes the vesolok is more brittle and does not have the same tactile closure as hemolok.The patient's condition was reported as fine.

• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15828510
• Report Number: 3011137372-2022-00219
• Device Sequence Number: 12301283
• Product Code: FZP
• UDI-Device Identifier: 24026704666823
• UDI-Public: 24026704666823
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2025
• Device Model Number: IPN055290
• Device Catalogue Number: 51114V
• Device Lot Number: 228044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Weight: 103 KG