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

Catalog Number 71114V

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that when clipping is used, cracks will break inside the cartridge.

Manufacturer Narrative

(b)(4).Per the dhr, lot number 9815 of product 71114v vlock xlg clip 6/cart 14/box was manufactured on 27feb2019.A total of (b)(4) pieces were released.The lot was released on 25mar2019.Dhr investigation did not show issues related to complaint.The complaint sample was not returned for investigation.Therefore, the root cause cannot be established.

Event Description

It was reported that when clipping is used, cracks will break inside the cartridge.

Manufacturer Narrative

Qn#(b)(4).After an additional medical review, a determination was made to re-classify complaint (b)(4) as a malfunction.There was no serious injury.Complaint (b)(4) is a malfunction.

• Brand Name: VLOCK XLG CLIP 6/CART 14/BOX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8937226
• MDR Text Key: 155781227
• Report Number: 3011137372-2019-00271
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K152082
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 08/12/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 71114V
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/12/2019
• Initial Date FDA Received: 08/27/2019
• Supplement Dates Manufacturer Received: 09/24/2019; 09/24/2019
• Supplement Dates FDA Received: 10/07/2019; 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention