Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK TAKEAPART ML 5MM ENDO APPLIER; APPLIER, SURGICAL, CLIP
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TELEFLEX MEDICAL HEMOLOK TAKEAPART ML 5MM ENDO APPLIER; APPLIER, SURGICAL, CLIP Back to Search Results
Catalog Number 544965T
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/30/2020
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 while applying clips on tissue it failed while in use on a patient.No further details are available so far.No clips fell/remained in the patient.
 
Manufacturer Narrative
Qn#(b)(4).Neither the instrument itself nor a lot number is available, therefore we cannot do a device history record (dhr) review nor can we expect the instrument to be returned.Therefore, no further measures will be initiated.However, the manufacturer will continue to trend relating complaints.
 
Event Description
It was reported that while applying clips on tissue it failed while in use on a patient.No further details are available so far.No clips fell/remained in the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HEMOLOK TAKEAPART ML 5MM ENDO APPLIER
Type of Device
APPLIER, SURGICAL, CLIP
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key9977599
MDR Text Key191027690
Report Number3011137372-2020-00103
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
Type of Report Initial,Followup
Report Date 03/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number544965T
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received05/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-