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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 Device Dislodged or Dislocated (2923)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 10/10/2023
Event Type  Injury  
Event Description
It was reported that "a laparoscopic spleen-sparing pancreatosplenectomy was performed for net.As the lower pole branch of the splenic artery was injured during the surgery, the physician ligated two clips in the center and one in the periphery and cut the artery between them.There was postoperative pancreatic fluid leakage, so the drain that was placed dorsally to the splenic artery and vein were left in place, and the patient was discharged two weeks after surgery.When the drain was removed two weeks after discharge, pulsatile bleeding was observed from the drain fistula.The physician performed endovascular treatment and could stop the bleeding by coiling.The bleeding was supposedly because the clips ligated at the lower pole branch of the splenic artery opened.No health consequence to the patient occurred".The patient status is reported as "fine".
 
Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
 
Event Description
It was reported that "a laparoscopic spleen-sparing pancreatosplenectomy was performed for net.As the lower pole branch of the splenic artery was injured during the surgery, the physician ligated two clips in the center and one in the periphery and cut the artery between them.There was postoperative pancreatic fluid leakage, so the drain that was placed dorsally to the splenic artery and vein were left in place, and the patient was discharged two weeks after surgery.When the drain was removed two weeks after discharge, pulsatile bleeding was observed from the drain fistula.The physician performed endovascular treatment and could stop the bleeding by coiling.The bleeding was supposedly because the clips ligated at the lower pole branch of the splenic artery opened.No health consequence to the patient occurred".The patient status is reported as "fine".
 
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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
mariah mackinnon
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key17996884
MDR Text Key326396979
Report Number3003898360-2023-01445
Device Sequence Number1
Product Code FZP
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K133202
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number544230
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/27/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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