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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK XL CLIPS 6/CART 84/BOX; CLIP, IMPLANTABLE
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TELEFLEX MEDICAL HEMOLOK XL CLIPS 6/CART 84/BOX; CLIP, IMPLANTABLE Back to Search Results
Catalog Number 544250
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/08/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that after smooth loading the first and second clips, the third clip was not loaded properly.The user stopped using the unit and opened a new one, however, the same issue occurred.He/she opened another unit by which completed the operation.No clips fell/remained in the patient.No further information was provided so far.It is unknown whether the clips got broken or deformed at present.
 
Manufacturer Narrative
(b)(4).Per dhr the product hemolok xl clips 6/cart 84/box lot# 73k1800244 was manufactured on 10/08/2018 a total of 16,926 pieces.Lot was released on 10/18/2018.Dhr investigation did not show issues related to complaint.The customer returned one cartridge 544250 hemolok xl clips 6/cart 84/box for investigation.The cartridge was visually examined with and without magnification.Visual examination of the returned cartridge revealed that it was returned with an intact clip loose from the fingers in the cartridge.The sample appears used as there is biological material present on the cartridge.The applier was not returned.Reference file (b)(4) for investigation photos.Functional inspection was performed on the returned clip.A lab inventory clip applier was used.The clip was manually loaded into the jaws of the applier.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 clip.Reference file (b)(4) for investigation photos.The ifu for this product, l06110 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 "difficulty loading clip into applier" was not confirmed based upon the sample received.Upon functional inspection, the clip was able to properly load into the jaws of the lab inventory applier and were successfully applied to over-stressed surgical tubing.Since no functional issues were found with the returned clip and the applier was not returned, the reported issue could not be confirmed.
 
Event Description
It was reported that after smooth loading the first and second clips, the third clip was not loaded properly.The user stopped using the unit and opened a new one, however, the same issue occurred.He/she opened another unit by which completed the operation.No clips fell/remained in the patient.No further information was provided so far.It is unknown whether the clips got broken or deformed at present.
 
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Brand Name
HEMOLOK XL CLIPS 6/CART 84/BOX
Type of Device
CLIP, IMPLANTABLE
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key9571122
MDR Text Key175838615
Report Number3003898360-2020-00117
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,u
Type of Report Initial,Followup
Report Date 01/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/07/2023
Device Catalogue Number544250
Device Lot Number73K1800244
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/17/2020
Date Manufacturer Received02/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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