MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK ML CLIPS 6/CART 84/BOX; CLIP, IMPLANTABLE

Model Number IPN915182

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/27/2022

Event Type  malfunction  

Event Description

The 6th clip got broken at loading during a robot-assisted pancreatic operation.Therefore, a new cartridge was opened instead.

Manufacturer Narrative

Qn#(b)(4).The device has not been returned for investigation.

Event Description

The 6th clip got broken at loading during a robot-assisted pancreatic operation.Therefore, a new cartridge was opened instead.

Manufacturer Narrative

(b)(4).Per dhr the product hemolok ml clips 6/cart 84/box lot# 73j2100172 was manufactured on 09/07/2021 a total of (b)(4) pieces.Lot was released on 09/24/2021.Dhr investigation did not show issues related to complaint.Visual inspection: it can be observed that only the cartridge was received empty and a broken clip (split in half in hinge section) was included, the broken clip was inspected with a vision system, the clip does not have marks, the number of cavities cannot be determinate due to the other side of the clip was not received.According to the report that the 6th clip got broken at loading during a robot-assisted pancreatic operation.Therefore, a new cartridge was opened instead.A verification of failure mode reported in the current manufacturing process was conducted as follows: 126 samples were taken from the current production p/n 544230 hemolok ml clips 6/cart 84/box, lot # 73f2200478, the samples were visually inspected , and issue reported "broken parts - clip - info not provided" was not observed in the current manufacturing process.Revision of pfmea-08-025 rev 06 was performed and the failure mode is already including it, no update is required.The returned clip was broken in half at the hinge during loading.The root cause is due to inadequate specifications for insert mismatch in the highest stress area of the hinge, which is a design related issue.A capa has been previously opened to further investigate issues related to clip breakages.A cartridge with catalog number 544230 hemolok ml clips 6/cart 84/box was received, batch number reported 73j2100172.The sample was received open and manipulated previously by user.The sample received was evaluated as follow: visual inspection: it can be observed that only the cartridge was received empty and a broken clip (split in half in hinge section) was included, the broken clip was inspected with a vision system, the clip does not have marks, the number of cavities cannot be determinate due to the other side of the clip was not received.According to the report that the 6th clip got broken at loading during a robot-assisted pancreatic operation.Therefore, a new cartridge was opened instead.Functional test: no additional clips were received to perform a functional test.Base on evaluation of complaint reported as "broken/detached parts - clip - hinge" it was concluded that defect reported was confirmed, however the root cause is not related to manufacturing issues, it could be a potential use error/improper loading.

• Brand Name: HEMOLOK ML CLIPS 6/CART 84/BOX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 14843799
• MDR Text Key: 301649671
• Report Number: 3003898360-2022-00276
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 24026704695915
• UDI-Public: 24026704695915
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/27/2022

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
• Device Operator: Health Professional
• Device Model Number: IPN915182
• Device Catalogue Number: 544230
• Device Lot Number: 73J2100172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2022
• Initial Date FDA Received: 06/28/2022
• Supplement Dates Manufacturer Received: 08/23/2022
• Supplement Dates FDA Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2021
• 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