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

Model Number	IPN028128
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history review for the product hemolok l clips 6/cart 84/box lot# 73c2000152 investigation did not show issues related to the complaint.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
It was reported that a clip got broken at the hook at ligation during a surgery.Therefore, a new cartridge was opened instead.No part of the broken clip fell inside the patient.
Event or Problem Description
It was reported that a clip got broken at the hook at ligation during a surgery.Therefore, a new cartridge was opened instead.No part of the broken clip fell inside the patient.
Additional Manufacturer Narrative
(b)(4) the customer returned one cartridge 544240 hemolok l clips 6/cart 84/box for investigation.The returned cartridge was examined with and without magnification.Visual examination revealed that the cartridge was returned with no clips remaining, but 3 loose clips were returned.The sample appears used as there was biological material on the clips and cartridge.Two of the clips were returned intact and one clip had broken pierced bosses.The broken pierced bosses were found within the cartridge.Functional inspection was performed on the 2 intact clips.A lab inventory clip applier was used and the clips were able to be manually loaded into the jaws of the applier and fired onto over-stressed surgical tubing.No functional issues were observed with the intact clips.R & d was consulted for this complaint issue.It was determined that the observed damage is consistent with improper loading of the clips.When the clip is loaded into the applier at an extreme angle from one direction, the pierce bosses break every time.It is also possible that using misaligned or damaged appliers could have caused this issue, however the appliers were not returned so this could not be confirmed.Therefore, based on the observed damages, unintentional user error caused or contributed to this event.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 observed damages indicate 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 cartridge was returned with 3 loose clips.Two clips were returned intact and one was returned with broken pierced bosses.The pierced bosses were found to be stuck in the bottom of the cartridge.Upon functional inspection, the 2 intact clips were manually loaded into the jaws of a lab inventory applier and successfully fired onto over-stressed surgical tubing.R & d was consulted for this complaint issue and it was determined that the observed damage is consistent with improper loading technique.When the clip is loaded into the applier at an extreme angle from one direction, the pierce bosses break every time.It is also possible that using misaligned or damaged appliers could have caused this issue, however the appliers were not returned so this could not be confirmed.A device history record review was performed on the device and showed no evidence to suggest a manufacturing related issue.Therefore, based on the obser ved damages, unintentional user error caused or contributed to this event.

• Brand Name: HEMOLOK L CLIPS 6/CART 84/BOX
• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11308514
• Report Number: 3003898360-2021-00151
• Device Sequence Number: 11054026
• Product Code: FZP
• UDI-Device Identifier: 34026704625209
• UDI-Public: 34026704625209
• 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): 01/29/2021

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 Expiration Date: 03/09/2025
• Device Model Number: IPN028128
• Device Catalogue Number: 544240
• Device Lot Number: 73C2000152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 03/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1