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

Model Number IPN915182

Device Problem Mechanical Jam (2983)

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

Event Date 03/23/2023

Event Type  malfunction  

Event Description

It was reported that a clip could not be loaded into the applier properly during use.The user opened another cartridge and could load the clips without problem to complete the procedure.No clip fell/remained in the patient.No patient harm or injury.Patient status reported as "fine".

Manufacturer Narrative

Qn#(b)(4).

Manufacturer Narrative

(b)(4).The customer returned one cartridge from one unit of 544230 hemolok ml clips 6/cart 84/box for investigation.The returned sample was visually examined with and without magnification.Three broken clips were returned in the cartridge.One hook half and three pierced boss halves were discovered within the returned cartridge.No other defects or anomalies were observed.Visual examination revealed that the broken clips were broken in half at the hinge.The clips breaking at the hinge during loading was determined to be the result of insert mismatch at the hinge area of the clip.Functional inspection could not be performed as there were no intact clips remaining in the cartridge.A device history record review was performed and no relevant findings were identified.The ifu for this product states, "always check the alignment of the applier jaws before use.When closed, jaw tips should be directly aligned and not offset.Alignment of the jaw is critical for safe application of the clip.If this is not done, patient injury may occur.Proper maintenance, care and cleaning are necessary to ensure proper functionality." the reported complaint was confirmed based upon the sample received.Three broken clips were returned in the cartridge.One hook half and three pierced boss halves were discovered within the returned cartridge.Visual inspection confirmed that the clips were broken at the hinge.The clips breaking at the hinge during loading was determined to be the result of insert mismatch at the hinge area on the pierce leg side of the hinge.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.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that a clip could not be loaded into the applier properly during use.The user opened another cartridge and could load the clips without problem to complete the procedure.No clip fell/remained in the patient.No patient harm or injury.Patient status reported as "fine".

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16856134
• MDR Text Key: 314466731
• Report Number: 3003898360-2023-00756
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/13/2023

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
• Device Operator: Health Professional
• Device Model Number: IPN915182
• Device Catalogue Number: 544230
• Device Lot Number: 73B2200435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/13/2023
• Initial Date FDA Received: 05/02/2023
• Supplement Dates Manufacturer Received: 05/30/2023
• Supplement Dates FDA Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1