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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK ML CLIPS 6/CART 84/BOX; CLIP, IMPLANTABLE
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TELEFLEX MEDICAL HEMOLOK ML CLIPS 6/CART 84/BOX; CLIP, IMPLANTABLE Back to Search Results
Catalog Number 544230
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2022
Event Type  malfunction  
Event Description
Plastic of cartridge was shredded on two different occasions.Not due to loading clips.These were both robotic cases.First cartridge was not noticed until after the 5th clip was placed and there were green plastic shards in the patient.2nd instance was noticed before clips were retrieved from the cartridge.
 
Manufacturer Narrative
Qn#(b)(4).The device history review for the product hemolok ml clips 6/cart 84/box lot# 73l2100830 investigation did not show issues related to the complaint.
 
Event Description
Plastic of cartridge was shredded on two different occasions.Not due to loading clips.These were both robotic cases.First cartridge was not noticed until after the 5th clip was placed and there were green plastic shards in the patient.2nd instance was noticed before clips were retrieved from the cartridge.
 
Manufacturer Narrative
(b)(4).The customer returned one cartridge 544230 hemolok ml clips 6/cart 84/box for investigation.The cartridge was returned with one intact clip and half of a broken clip remaining.The returned cartridge was the first cartridge used in the procedure.Refer to tc 1900091069 for the second cartridge that was used.The cartridge was visually examined with and without magnification.Visual examination of the returned sample revealed that the cartridge was heavily damaged as it had multiple scrape marks on it.The broken clip that was returned was the pierced boss half and was broken in half at the hinge.It appears that when the user went to load a clip into the applier, the applier scraped material off of the cartridge.The damage to the cartridge is consistent with improper loading of the clips or using damaged/misaligned appliers.This would have also caused the clip to break upon loading.The applier was not returned.Therefore, unintentional user error appears to have caused or contributed to this issue.Functional testing was performed on the remaining clip.A lab inventory applier was used.The intact clip was able to be properly loaded into the jaws of the applier and was successfully applied to over-stressed surgical tubing.A piece of the cartridge was on the clip due to the cartridge already being heavily damaged.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 since the damage observed to the cartridge indicates that unintentional user error caused or contributed to this event.The reported defect of "broken/detached parts - cartridge" was confirmed based on the returned sample.The returned cartridge was the first cartridge used in the procedure.Refer to tc 1900091069 for the second cartridge that was used.Visual examination of the returned sample revealed that the cartridge was heavily damaged due to multiple scrape marks.There was also a broken clip in the cartridge.It appears that when the user went to load a clip into the applier, the applier scraped material off the cartridge.The damage to the cartridge is consistent with improper loading of the clips or using damaged/misaligned appliers which would also cause the clip to break upon loading.The applier was not returned.Therefore, unintentional user error appears to have caused or contributed to this issue.
 
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Brand Name
HEMOLOK ML 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 Key13894839
MDR Text Key288683352
Report Number3003898360-2022-00084
Device Sequence Number1
Product Code FZP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133202
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number544230
Device Lot Number73L2100830
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/21/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received04/21/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/23/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
Treatment
N/A.
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