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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK L CLIPS; CLIP, IMPLANTABLE
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TELEFLEX MEDICAL HEMOLOK L CLIPS; CLIP, IMPLANTABLE Back to Search Results
Catalog Number SURGICAL UNKNOWN
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 11/01/2023
Event Type  malfunction  
Event Description
"reported in the 37th congress of japanese society of endourology and robotics: while dissecting a large inter-arterial lymph node, hem-o-lok clip over the root of the lumbar vein was off, causing bleeding from the inferior vena cava (ivc).The user interrupted the ivc cephalad of the bleeding site, suture-ligated it with 3-0 polysorb and stopped the bleeding.The ivc was blocked for 10 minutes.The bleeding volume was 100 ml.No transfusion was required during the perioperative period.The patient had a good postoperative course and was discharged on postoperative day 8." the patient status is reported as "fine".
 
Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
 
Manufacturer Narrative
(b)(4).Upon further review, it was determined that this complaint was created in error, thus, the initial mdr submitted on 09 november 2023 should be retracted.
 
Event Description
"reported in the 37th congress of japanese society of endourology and robotics: while dissecting a large inter-arterial lymph node, hem-o-lok clip over the root of the lumbar vein was off, causing bleeding from the inferior vena cava (ivc).The user interrupted the ivc cephalad of the bleeding site, suture-ligated it with 3-0 polysorb and stopped the bleeding.The ivc was blocked for 10 minutes.The bleeding volume was 100 ml.No transfusion was required during the perioperative period.The patient had a good postoperative course and was discharged on postoperative day 8." the patient status is reported as "fine".
 
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Brand Name
HEMOLOK L CLIPS
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
bryanna connelly
3015 carrington mill blvd
morrisville 27560
MDR Report Key18107036
MDR Text Key327790069
Report Number3003898360-2023-01519
Device Sequence Number1
Product Code FZP
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/01/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberSURGICAL UNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/01/2023
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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