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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
Model Number IPN915182
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been returned for investigation.The device history review for the product hemolok ml clips 6/cart 84/box lot# 73a2000409.Investigation did not show issues related to the complaint.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that, when the user attempted to ligate a clip during a surgery, it got stuck in the applier.The user put the applier and the clip out of the patient body and took the clip out of the applier with a forceps.The surgery was completed with a new applier and clips.
 
Manufacturer Narrative
(b)(4).The customer returned one cartridge 544230 hemolok ml clips 6/cart 84/box for investigation.One loose clip was also returned closed.The appliers were also returned under tc 1900083514 for a separate investigation.The clip and cartridge were visually examined with and without magnification.Visual examination of the returned cartridge revealed that there was 1 clip remaining in the cartridge.The closed clip appeared typical.Functional inspection was performed on the remaining clip.The clip was able to properly load into the jaws of the applier and was successfully applied to over-stressed surgical tubing.No functional issues were found with the returned clips.It is possible that the reported issue of "clip stuck in applier" was caused by using damaged/misaligned appliers, but this could not be confirmed since the appliers are under a separate investigation.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 sample.The reported complaint of "clips stuck in applier" was not confirmed based upon the sample received.One loose clip was returned closed and no defects or anomalies were observed with this clip.The cartridge was also returned with one clip remaining.Upon functional inspection, the remaining clip was able to properly load into the jaws of a lab inventory applier and successfully fired onto over-stressed surgical tubing.No damages were observed on the returned clips.It is possible that the reported issue of was caused by using damaged/misaligned appliers, but this could not be confirmed since the applier is under a separate investigation.Since no functional issues were found with the returned clips, the reported issue could not be confirmed.
 
Event Description
It was reported that, when the user attempted to ligate a clip during a surgery, it got stuck in the applier.The user put the applier and the clip out of the patient body and took the clip out of the applier with a forceps.The surgery was completed with a new applier and clips.
 
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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 Key11581035
MDR Text Key242690753
Report Number3003898360-2021-00302
Device Sequence Number1
Product Code FZP
UDI-Device Identifier24026704695915
UDI-Public24026704695915
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 03/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN915182
Device Catalogue Number544230
Device Lot Number73A2000409
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/01/2021
Date Manufacturer Received04/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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