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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL L 10MM ENDO APPLIER; APPLIER,SURGICAL, CLIP
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TELEFLEX MEDICAL HOL L 10MM ENDO APPLIER; APPLIER,SURGICAL, CLIP Back to Search Results
Catalog Number 544995
Device Problems Failure to Align (2522); Activation, Positioning or Separation Problem (2906)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/17/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been returned for investigation at this time.The manufacturer will continue to monitor and trend related events.
 
Event Description
The applier would not hold or close properly due to the jaws being misaligned.The applier was replaced and the procedure was completed successfully.No clips fell into the patient's body.The patient's condition was reported as fine.
 
Manufacturer Narrative
(b)(4).Since this instrument was not returned for evaluation and lot information has not been provided, we are unable to determine where and when it was produced or perform a thorough dhr review at this time.Since the instrument was not returned for evaluation and pictures were not provided we are unable to validate this complaint or determine root cause at this time.All instruments are thoroughly inspected and function tested at time of manufacture.No corrective action required at this time.
 
Event Description
The applier would not hold or close properly due to the jaws being misaligned.The applier was replaced and the procedure was completed successfully.No clips fell into the patient's body.The patient's condition was reported as fine.
 
Manufacturer Narrative
(b)(4).The dhr for the instruments in question, was reviewed and found complete without any irregularities.This instrument was manufactured at the tecomet, (b)(4) facility as part of a 50pc.Lot in december of 2014.The returned instrument was evaluated and found that the jaws are aligned properly with each other in both the open and closed positions thus we are unable to validate the alleged complaint.Further evaluation showed that this instrument picks up, retains, closes and releases clips as required of its function both with and without the use of silastic test tubing as required of its function.Parts were 100% visually inspected and tested at the tecomet, (b)(4) 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.At this time, it is un-determined what caused the alleged issue at the customer's facility.No corrective action required at this time.Per fda guidelines for manufacturers which state: "manufacturers are required to report to the fda when they learn that any of their devices may have caused or contributed to a death or serious injury.Other remarks: manufacturers must also report to the fda when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur." this incident is not reportable at this time with the information provided.No corrective action required at this time.
 
Event Description
The applier would not hold or close properly due to the jaws being misaligned.The applier was replaced and the procedure was completed successfully.No clips fell into the patient's body.The patient's condition was reported as fine.
 
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Brand Name
HOL L 10MM ENDO APPLIER
Type of Device
APPLIER,SURGICAL, CLIP
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
3015 carrington mill blvd
morrisville NC 27560
Manufacturer Contact
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key6147371
MDR Text Key61548576
Report Number3011137372-2016-00352
Device Sequence Number1
Product Code GDO
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 11/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number544995
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/26/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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