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	11/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
The user was unable to ligate a clip properly during an urological surgery.On checking the clip was found broken.Although the clip fell in the cavity it was withdrawn.The user opened a new cartridge to complete the surgery.
Additional Manufacturer Narrative
(b)(4).Although a lot number was not initially reported, a potential lot number was obtained through the sales history.The potential lot# is 73e2100503.Per dhr the product hemolok xl clips 6/cart 42/box lot# 73e2100503 was manufactured on 05/18/2021 a total of 10,052 pieces.Lot was released on 05/31/2021.Dhr investigation did not show issues related to complaint.The customer returned one clip from unit 544250 hemolok xl clips 6/cart 42/box for investigation.The cartridge was not returned.The loose clip was visually examined with and without magnification.Visual examination revealed that the clip had one pierced boss broken off which was also returned.The boss appears to have been torn off the clip since the material around the broken boss was stretched.Biological material was observed on the clip, indicating that the sample was used.R & d engineering was consulted for this complaint issue.According to r & d, the observed damage to the broken clip and cartridge is consistent with improper loading of the clips or with using damaged appliers.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 damage observed on the clip indicates that unintentional user error caused or contributed to this event.The reported complaint of "broken/detached parts - clip - boss" was confirmed based upon the sample received.One loose clip was returned with a pierced boss broken off.The broken boss was also returned.R & d was consulted for this complaint and it was determined that the observed damage to the broken clip/boss is consistent with improper loading of the clip or with using damaged appliers.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, unintentional user error caused or contributed to this event.
Event or Problem Description
The user was unable to ligate a clip properly during an urological surgery.On checking the clip was found broken.Although the clip fell in the cavity it was withdrawn.The user opened a new cartridge to complete the surgery.

• 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: 12827949
• Report Number: 3003898360-2021-01061
• Device Sequence Number: 19192836
• Product Code: FZP
• UDI-Device Identifier: 24026704695953
• UDI-Public: 24026704695953
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 11/16/2021

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: IPN915186
• Device Catalogue Number: 544250
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2021
• Supplement Date Received by Manufacturer: 01/06/2022
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 01/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown