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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 Problems Break (1069); Device Fell (4014)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/31/2019
Event Type  Injury  
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 a clip got broken at ligation during a laparoscopic sigmoidectomy.A half of the broken piece was retrieved, whereas other half was not found although the md searched in the abdominal cavity endoscopically.No health injury to the patient was reported.
 
Event Description
It was reported that a clip got broken at ligation during a laparoscopic sigmoidectomy.A half of the broken piece was retrieved, whereas other half was not found although the md searched in the abdominal cavity endoscopically.No health injury to the patient was reported.
 
Manufacturer Narrative
(b)(4).Per dhr the product hemolok ml clips 6/cart 84/box lot#: 73h1800872 was manufactured on 08/31/2018 a total of 10,878 pieces.Lot was released on 09/17/2018.Dhr investigation did not show issues related to complaint.The customer returned one cartridge 544230 hemolok ml clips 6/cart 84/box for investigation.A half of a loose clip was also returned.The cartridge and the clip were visually examined with and without magnification.Visual examination of the cartridge revealed that the cartridge was returned with no clips remaining in it.A broken piece of a clip was found in the bottom of the cartridge.The returned clip appears used as there is biological material present on the clip and the cartridge.The loose clip exhibited a staggered break where it was broken in the center of the outer hinge but also broken at the inner hinge on one side of the hinge span.The clip breaking at the hinge during loading was determined to be the result of inadequate cross-sectional area at the outer hinge.The root cause is due to inadequate specification of hinge thickness, which is a design related issue.A capa has been previously opened to further investigate issues related to clip breakages.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 loose clip had a staggered break at the hinge which was determined to be the result of inadequate cross-sectional area at the outer hinge.The root cause is due to inadequate specification of hinge thickness, which is a design related issue.A capa has been previously opened to further investigate issues related to clip breakages.The reported complaint of "broken/detached parts - clip - hinge" was confirmed based upon the sample received.One cartridge and a half of a loose clip was returned.The cartridge was returned with no clips remaining in it.A broken piece of a clip was found in the bottom of the cartridge.The loose clip exhibited a staggered break, where it was broken in the center of the outer hinge but also broken at the inner hinge on one side of the hinge span.The clip breaking at the hinge during loading was determined to be the result of inadequate cross-sectional area at the outer hinge.The root cause is due to inadequate specification of hinge thickness, which is a design related issue.A capa has been previously opened to further investigate issues related to clip breakages.
 
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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 Key9356193
MDR Text Key167602478
Report Number3003898360-2019-01415
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 11/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/30/2023
Device Catalogue Number544230
Device Lot Number73H1800872
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2019
Initial Date Manufacturer Received 11/06/2019
Initial Date FDA Received11/21/2019
Supplement Dates Manufacturer Received12/20/2019
Supplement Dates FDA Received01/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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