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

Model Number IPN915184

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 01/12/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review the product hemolok l clips 6/cart 84/box lot# 73c2100138 investigation did not show issues related to complaint.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

The clips were not loaded into the applier properly before use on a patient.The user opened another unit, however, the same issue occurred.He/she opened the third unit of a different lot, by which could load the clips properly.

Event Description

The clips were not loaded into the applier properly before use on a patient.The user opened another unit, however, the same issue occurred.He/she opened the third unit of a different lot, by which could load the clips properly.

Manufacturer Narrative

(b)(4).The customer returned one cartridge from unit 544240 hemolok l clips 6/cart 84/box for investigation.Two loose clips were also returned.The returned sample was visually examined with and without magnification.Visual examination revealed that the cartridge had no clips remaining.One of the loose clips had a gouge in the hook.The other clip was intact with no abnormalities.The appliers were not returned for investigation.Functional inspection was performed on both clips that were returned.A lab inventory applier was used.Both clips were manually loaded into the jaws of the applier and were successfully applied to over-stressed surgical tubing.The observed damage to the hook of one of the clips is consistent with improper loading of the clips or with using damaged appliers.Therefore, unintentional user error appears to have caused or contributed to this issue.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 "difficulty loading clip into applier" was confirmed based upon the sample received.Two loose clips were returned with an empty cartridge.One of the clips had a gouge in the hook.The observed damage to the hook 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 used at the time of malfunction were not returned for investigation.Therefore, based upon the damage observed, unintentional user error caused or contributed to this event.

• Brand Name: HEMOLOK L 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 13343763
• MDR Text Key: 284524422
• Report Number: 3003898360-2022-00010
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 24026704695939
• UDI-Public: 24026704695939
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN915184
• Device Catalogue Number: 544240
• Device Lot Number: 73C2100138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1