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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK TAKEAPART ML 5MM ENDO APPLIER; APPLIER, SURGICAL, CLIP
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TELEFLEX MEDICAL HEMOLOK TAKEAPART ML 5MM ENDO APPLIER; APPLIER, SURGICAL, CLIP Back to Search Results
Model Number IPN915191
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/15/2022
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 during a surgery, a clip got broken at ligation, another clip was not loaded to the applier properly, and the other clip got broken at the hinge at loading.The user managed to complete the surgery with the applier.The fragment of the clip fell in the patient, but all of them were removed and discarded.No patient injury occurred.The user made an inquiry to us that the clips might have been defective first, but when our sales representative visited the hospital and checked the applier, he found that the jaws were slightly deformed.
 
Manufacturer Narrative
(b)(4).The instrument with lot w1-01 was shipped to tfx with invoice (b)(4) of 22/11/21.Original manufacturing lot is 22142129, hr review: upon review of the device history records for the affected lot number, we can confirm that both the correct material and correct components had been used and that the instrument meets the product specifications.All process steps were found to have been properly documented.100% functional test at final inspection found good.The dimensional check did not reveal any deviating dimensions.Clips were picked up and applied without any problems, and the visual inspection showed no evidence of a bent jaw.A bent pull wire was detected, which had no effect on the pick-up and application of clips.The instrument is working properly and is not the cause of the error.Possible causes are user errors, as indicated by the bent pull wire due to strong force, or faulty clips.No further measures will be initiated by (b)(4); this complaint is being rejected by us.
 
Event Description
It was reported that during a surgery, a clip got broken at ligation, another clip was not loaded to the applier properly, and the other clip got broken at the hinge at loading.The user managed to complete the surgery with the applier.The fragment of the clip fell in the patient, but all of them were removed and discarded.No patient injury occurred.The user made an inquiry to us that the clips might have been defective first, but when our sales representative visited the hospital and checked the applier, he found that the jaws were slightly deformed.
 
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Brand Name
HEMOLOK TAKEAPART ML 5MM ENDO APPLIER
Type of Device
APPLIER, SURGICAL, CLIP
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
Manufacturer (Section G)
TELEFLEX MEDICAL
3015 carrington mill blvd
morrisville NC 27560
Manufacturer Contact
effie jefferson
3015 carrington mill blvd
morrisville 27560
9194332672
MDR Report Key16095799
MDR Text Key308443208
Report Number3011137372-2023-00003
Device Sequence Number1
Product Code GDO
UDI-Device Identifier24026704697841
UDI-Public24026704697841
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN915191
Device Catalogue Number544965T
Device Lot NumberW1-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/10/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/07/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
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