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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 Activation, Positioning or Separation Problem (2906)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/17/2021
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).The device history review could not be conducted since the lot number was not provided.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
When the user attempted to ligate a clip during a surgery, it got stuck in the applier.Also, it did not close.The user loaded another clip and tried to ligate, but the same issue occurred.Therefore, a new cartridge was opened instead.No clip fell/remained in the patient.
 
Manufacturer Narrative
(b)(4).Per dhr the product hemolok ml clips 6/cart 84/box lot#: 73c2000219 was manufactured on 03/17/2020 a total of (b)(4) pieces.Lot was released on 03/25/2020.Dhr investigation did not show issues related to complaint.The customer returned four cartridges of 544230 hemolok ml clips 6/cart 84/box for investigation.One of the cartridges was the actual sample related to the complaint, the other 3 were representative samples that were returned closed in their original packaging.(b)(4) also applies to these samples.The cartridges were visually examined with and without magnification.Visual examination of the actual sample cartridge revealed that there were 2 clips remaining in the cartridge.There was also one loose clip returned closed.The loose clip appeared used as there was biological material observed on the clip.There were no damages or defects observed with the closed loose clip.The 3 representative cartridges appeared typical.The clip applier was not returned.Functional inspection was performed on the returned samples.A lab inventory clip applier was used.The two remaining clips from the actual sample were both able to properly load into the jaws of the applier and successfully fire onto over-stressed surgical tubing.These actions were repeated for the representative samples and all 18 representative clips had the same results.No functional issues were found with the returned clips.It is possible that the reported issue of clips not closing/locking was caused by using damaged or misaligned appliers, but this could not be confirmed since the appliers were not returned.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 there were no functional issues found with the returned samples.The actual sample and representative samples were all able to properly load and fire onto surgical tubing.The reported complaint of "clips not closing/locking" was not confirmed based upon the sample received.The customer returned one opened cartridge which was the actual sample and 3 representative cartridges that were closed in their original packaging.The actual sample had 2 clips remaining and one loose clip which was returned closed.Upon functional inspection, all returned clips were able to properly load into the jaws of a lab inventory applier and successfully fire onto over-stressed surgical tubing.No damages were observed to any of the returned clips.It is possible that the reported issue was caused by using damaged or misaligned appliers, but this could not be confirmed since the applier was not returned.Since no functional issues were found with the returned clips, the reported issue could not be confirmed.
 
Event Description
When the user attempted to ligate a clip during a surgery, it got stuck in the applier.Also, it did not close.The user loaded another clip and tried to ligate, but the same issue occurred.Therefore, a new cartridge was opened instead.No clip fell/remained in the patient.
 
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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
MDR Report Key12075278
MDR Text Key258638682
Report Number3003898360-2021-00581
Device Sequence Number1
Product Code FZP
Combination Product (y/n)N
PMA/PMN Number
K133202
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 06/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number544230
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2021
Date Manufacturer Received08/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
N/A.
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