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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL L 10MM ENDO APPLIER
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TELEFLEX MEDICAL HOL L 10MM ENDO APPLIER Back to Search Results
Catalog Number 544995
Device Problems Premature Activation (1484); Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/27/2015
Event Type  malfunction  
Event Description
Alleged event: after using the applier several times, mal-alignment of jaw occurred and clipping by the applier was not possible.The clip was dropped in the patient's body but it was removed.No additional intervention was necessary.The patient's condition was reported as fine.
 
Manufacturer Narrative
(b)(4).The device sample has not been returned to the manufacturer for investigation at the time of the report.The manufacturer will continue to monitor and trend related events.
 
Manufacturer Narrative
(b)(4).The device history record (dhr) for the instruments in question was reviewed and found completely without any irregularities.The returned instrument was evaluated and found that the jaws are slightly misaligned with each other in the closed position as stated in the complaint thus validating this complaint.Further evaluation shows that; although the jaws are slightly misaligned that this instrument picks up, retains, closes and releases clips both with and without the use of silastic test tubing as required of its function.Parts were 100% visually inspected and tested at the manufacturing facility before instruments were sent to customer.No irregularities were found and/or reported at the time of inspection and assembly of the product, as this is a standardized process for all instruments manufactured at this facility.We are unable to determine what caused the tips to be misaligned with each other, but mishandling at the customers facility is suspected.No corrective action required at this time.
 
Event Description
Alleged event: after using the applier several times, mal-alignment of jaw occurred and clipping by the applier was not possible.The clip was dropped in the patient's body but it was removed.No additional intervention was necessary.The patient's condition was reported as fine.
 
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Brand Name
HOL L 10MM ENDO APPLIER
Type of Device
APPLIER
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
2917 weck drive
research triangle park NC 27709
Manufacturer Contact
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key4912748
MDR Text Key6027013
Report Number1044475-2015-00197
Device Sequence Number1
Product Code GEF
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,company represent
Reporter Occupation Other
Type of Report Initial
Report Date 06/16/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number544995
Device Lot Number06F1388072
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/16/2015
Initial Date FDA Received07/14/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Patient Sequence Number1
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