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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK TAKEAPART LG 10MM ENDO APPLIER; APPLIER, SURGICAL, CLIP
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TELEFLEX MEDICAL HEMOLOK TAKEAPART LG 10MM ENDO APPLIER; APPLIER, SURGICAL, CLIP Back to Search Results
Catalog Number 544995T
Device Problem Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/06/2019
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 the hem-o-loc does not open completely after a clip has been placed.We have the product available to be sent in return to teleflex.Clinical consequences: no patient injury has been reported.
 
Event Description
It was reported that the hem-o-loc does not open completely after a clip has been placed.We have the product available to be sent in return to teleflex.Clinical consequences: no patient injury has been reported.
 
Manufacturer Narrative
Qn#(b)(4).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.A functional test was performed , and everything found good.As we cannot replicate the problem , we are unable to determine a root cause.No further measures will be initiated.However, we will continue to monitor and trend relating complaints.
 
Manufacturer Narrative
Qn#(b)(4).Additional information received: the product was used during robot assisted radical prostatectomy.During the procedure it was noticed that the product did not open completely by itself.To make it fully open the nurse took the handle and forced it to fully open as when opening a pair of scissors by pushing the two parts of the handle apart.The clip was not placed around a vessel but around vessel containing tissue.The pliers could release the clip but not open so the staff could completely remove the pliers from the clip.No clips fell into the patient.The procedure could be completed by the assistant opening the plier as described above.
 
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Brand Name
HEMOLOK TAKEAPART LG 10MM ENDO APPLIER
Type of Device
APPLIER, SURGICAL, CLIP
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key9489909
MDR Text Key190850054
Report Number3011137372-2019-00429
Device Sequence Number1
Product Code GDO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup,Followup
Report Date 12/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number544995T
Device Lot NumberG8-03
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/09/2020
Date Manufacturer Received03/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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