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

Catalog Number 544250

Device Problem Break (1069)

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

Event Date 11/08/2022

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related event.

Event Description

It was reported that a clip was found broken when the user attempted to ligate splenic artery during surgery.No clip fell or remained in the patient's body.After procedure, the user found a fragment of the clip in the cartridge.

Manufacturer Narrative

(b)(4).The customer returned one lidstock, one broken clip, and one cartridge with four intact clips from one unit of 544250 hemolok xl clips 6/cart 84/box for investigation.The cartridge and clips were visually examined with and without magnification.Visual examination revealed that the broken clip was broken at the pierced bosses and inner hinge.The broken pierced bosses were found in the bottom of the cartridge.The sample appeared used as there was biological material on the cartridge.R & d engineering was consulted for this complaint issue.According to r & d, sem analysis and the broken pierced bosses in the cartridge indicate that this issue is a result of excessive force during loading.Therefore, unintentional user error appears to have caused or contributed to this issue.Functional inspection was performed on the four intact clips returned in the cartridge.A lab inventory applier was used.All four clips were manually loaded into the jaws of the applier and were successfully applied to over-stressed surgical tubing without breaking.Per dhr the product hemolok xl clips 6/cart 84/box lot# 73k2100886 was manufactured on 10/26/2021 a total of 14,994 pieces.Lot was released on 11/04/2021.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." the reported complaint of "broken clip - multiple locations" was confirmed based upon the sample received.One cartridge with four intact clips and one broken clip was returned.The broken clip had broken pierced bosses and a broken inner hinge.R & d was consulted for this complaint, and it was determined that the observed damage to the broken clip is consistent with excessive force during loading of the clip.No issues were observed with the returned intact clips.Therefore, based upon the returned sample, unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

It was reported that a clip was found broken when the user was attempted to ligate splenic artery during surgery.No clip fell or remained in the patient's body.After procedure, the user found a fragment of the clip in the cartridge.

• Brand Name: HEMOLOK XL 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15781066
• MDR Text Key: 306622148
• Report Number: 3003898360-2022-00727
• Device Sequence Number: 1
• Product Code: FZP
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 544250
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED