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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
(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.
 
Manufacturer Narrative
(b)(4), per dhr the product hemolok ml clips 6/cart 84/box lot# 73l2100830 was manufactured on 11/23/2021 a total of (b)(4) pieces.Lot was released on 12/06/2021.Dhr investigation did not show issues related to complaint.The customer returned one cartridge 544230 hemolok ml clips 6/cart 84/box for investigation.The cartridge was returned with 5 clips remaining.The returned cartridge was the second cartridge used in the procedure.Refer to (b)(6) for the first cartridge that was used.The cartridge was visually examined with and without magnification.Visual examination of the returned sample revealed that the empty slot in the cartridge had multiple scrape marks.Additionally, the first cartridge that was used ((b)(6)) was heavily damaged.It appears that when the user went to load a clip into the applier, the applier scraped a piece of material off the cartridge or there was leftover cartridge residue from the first cartridge on the applier jaws.The damage to the cartridge is consistent with improper loading of the clips or using damaged/misaligned appliers.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 clips.A lab inventory applier was used.All 5 clips were able to be properly loaded into the jaws of the applier and were successfully applied to over-stressed surgical tubing without any pieces of the cartridge being scraped off.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 second cartridge used in the procedure.Refer to (b)(6) for the first cartridge that was used.Visual examination of the returned sample revealed that the empty slot in the cartridge had multiple scrape marks.Additionally, the first cartridge that was used ((b)(6)) was heavily damaged.It appears that when the user went to load a clip into the applier, the applier scraped a piece of material off the cartridge or there was leftover cartridge residue from the first cartridge on the applier jaws.The damage to the cartridge is consistent with improper loading of the clips or using damaged/misaligned appliers.The applier was not returned.Therefore, unintentional user error appears to have caused or contributed to this issue.
 
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.
 
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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 Key13904346
MDR Text Key287917058
Report Number3003898360-2022-00079
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 Received03/25/2022
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
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