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 HOL 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 HOL ML 5MM ENDO APPLIER; APPLIER,SURGICAL, CLIP Back to Search Results
Catalog Number 544965
Device Problems Positioning Failure (1158); Separation Failure (2547)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/10/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been returned for investigation at this time.Teleflex will continue to monitor and trend related events.
 
Event Description
The physician ligated the lymphatic vessel which was not to be removed but a clip remained stuck in the jaws of applier and the physician was not able to open the jaws.Therefore, the physician removed the ligated part of vessel together with the clip and applier.No clips fell from the applier in the patient.There was no reported patient's death or injury as a result of this issue.
 
Manufacturer Narrative
(b)(4).The dhr for the instruments in question was reviewed and found completely without any irregularities.This instrument was manufactured at the (b)(4) as part of a (b)(4) lot in april of 2016.The returned instrument was evaluated and found that the knob rotation is dry and slightly sluggish.Further evaluation showed that this instrument picks up, retains, closes and releases multiple clips as required of its function both with and without the use of silastic test tubing.Parts were 100% visually inspected and tested at the (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, but it is suspected that the customer did not "lubricate" the instrument prior to sterilization as recommended in ifu (l06109 r04) supplied with the instrument which states "the instrument must be cleaned, lubricated, functionally checked, and sterilized prior to each use.Use a non-silicone, water-based lubricant prior to sterilization.No corrective action required at this other remarks: 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.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.
 
Event Description
The physician ligated the lymphatic vessel which was not to be removed but a clip remained stuck in the jaws of applier and the physician was not able to open the jaws.Therefore, the physician removed the ligated part of vessel together with the clip and applier.No clips fell from the applier in the patient.There was no reported patient's death or injury as a result of this issue.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HOL ML 5MM 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 Key6724726
MDR Text Key80421608
Report Number3011137372-2017-00238
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
Report Date 07/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number544965
Device Lot Number06B1629330
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/21/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/06/2017
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
-
-