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

Model Number	IPN915184
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reported issue: a large weck hem-o-loc clip was being placed on a vessel with robot when the clip broke in half at the hinge side of the clip.The broken clip was removed from the patient and a new clip was used without further incident.Patient was not injured nor adverse impact occurring as a result.
Additional Manufacturer Narrative
Qn#: (b)(4).The device history review for the product hemolok l clips 6/cart 84/box lot#: 73g2200746 investigation did not show issues related to the complaint.
Event or Problem Description
Reported issue: a large weck hem-o-loc clip was being placed on a vessel with robot when the clip broke in half at the hinge side of the clip.The broken clip was removed from the patient and a new clip was used without further incident.Patient was not injured nor adverse impact occurring as a result.
Additional Manufacturer Narrative
(b)(4).The customer returned one cartridge of 544240 hemolok l clips 6/cart 84/box for investigation.The returned sample was visually examined with and without magnification.Visual examination of the returned device revealed that the cartridge was returned with no clips remaining.The clip applier was not returned.Per dhr the product hemolok l clips 6/cart 84/box lot# 73g2200746 was manufactured on 07/25/2022 a total of (b)(4) pieces.Lot was released on 08/12/2022.Dhr investigation did not show issues related to complaint.The ifu for this product, l02425 rev 02, was reviewed as a part of this complaint investigation.The ifu 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." a corrective action is not required at this time as it could not be determined what caused the complaint issue since no clips were remaining in the returned cartridge.The device history record review showed no evidence to suggest a manufacturing related cause.The reported complaint of "broken/detached parts - clip - hinge" for (b)(4) was not confirmed based upon the sample received.One cartridge was returned, but no clips were remaining in the cartridge.Since no clips were returned, the reported complaint issue could not be confirmed and a probable cause could not be determined.A device history record review showed no evidence to suggest a manufacturing related cause.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: HEMOLOK L CLIPS 6/CART 84/BOX
• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16639178
• Report Number: 3003898360-2023-00522
• Device Sequence Number: 12396903
• Product Code: FZP
• UDI-Device Identifier: 24026704695939
• UDI-Public: 24026704695939
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K133202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2023

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 Model Number: IPN915184
• Device Catalogue Number: 544240
• Device Lot Number: 73G2200746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2023
• Supplement Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2022
• 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