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

Model Number	IPN915186
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2022
Type of Reportable Event	Malfunction
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
(b)(6) 2021, clip was found broken during using on the patient.The severed part has been removed from the patient with no adverse feedback.Involved 1 cartridge.
Event or Problem Description
(b)(6) 2021, clip was found broken during using on the patient.The severed part has been removed from the patient with no adverse f eedback.Involved 1 cartridge.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one cartridge from unit 544250 hemolok xl clips 6/cart 42/box for investigation.One loose clip and the product packaging were also returned.The cartridge and loose clip were visually examined with and without magnification.Visual examination revealed that the clip was broken on the hook side leg, near the hook.No clips were remaining in the cartridge.The sample appeared used as there was biological material on the cartridge and clip.R & d engineering was consulted for this complaint issue.According to r & d, the root cause for the broken leg could not be determined.There are no indications that the clip broke due to a manufacturing issue.It is possible that the clip broke on the leg near the hook due to improper loading or by using damaged/misaligned appliers, but this could not be confirmed.The appliers were not returned for investigation.The ifu for this product, l02425, 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 the root cause could not be determined.We will continue to monitor and trend on this issue.The reported complaint of "broken/detached parts - clip - leg" was confirmed based upon the sample received.The cartridge was returned with no clips remaining, but a loose clip was also returned.The loose clip was broken on the hook side leg near the hook.R & d engineering was consulted for this complaint issue.According to r & d, the root cause for the broken leg could not be determined.There are no indications that the clip broke due to a manufacturing issue.It is possible that the clip broke due to improper loading or by using damaged/misaligned appliers, but this could not be confirmed.It is unknown how the returned clip was handled during use and the appliers were not returned for investigation.Therefore, based upon the damage observed and the information provided, the root cause could not be determined.We will continue to monitor and trend on this issue.
Event or Problem Description
(b)(6) 2021, clip was found broken during using on the patient.The severed part has been removed from the patient with no adverse f feedback.Involved 1 cartridge.
Additional Manufacturer Narrative
Qn#(b)(4).Per dhr the product hemolok xl clips 6/cart 84/box lot# 73b2000575 was manufactured on 02/25/2020 a total of (b)(4) pieces.Lot was released on 03/18/2020.Dhr investigation did not show issues related to complaint.P/n 544240 is not being manufactured currently, however, another part number from the same family was use for the "verification of failure mode reported in the current manufacturing process" and was conducted as follows: 125 samples were taken from the current production p/n 544253 hemolok xl clips 3/cart 42/box lot # 73a2200396, the samples were visually inspected, and during the test issue reported "broken parts - clip - info not provided" was not observed in the current manufacturing process.Revision of pfmea-08-025 rev 05 was performed and the failure mode is already including it, no update is required.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time due the sample is not available is not possible to determine the source of the defect reported.Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause.

• Brand Name: HEMOLOK XL 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 13342287
• Report Number: 3003898360-2022-00020
• Device Sequence Number: 3918821
• Product Code: FZP
• UDI-Device Identifier: 24026704695953
• UDI-Public: 24026704695953
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/19/2022

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: 02/24/2025
• Device Model Number: IPN915186
• Device Catalogue Number: 544250
• Device Lot Number: 73B2000575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2022
• Supplement Date Received by Manufacturer: 01/26/2022; 03/18/2022
• Initial Report FDA Received Date: 01/25/2022
• Supplement Report FDA Received Date: 02/21/2022; 03/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2020
• 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
• Patient Sex: Unknown