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 AUTO ENDO5 ML; CLIP, IMPLANTABLE
  • 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 AUTO ENDO5 ML; CLIP, IMPLANTABLE Back to Search Results
Catalog Number AE05ML
Device Problems Failure to Advance (2524); Device Fell (4014)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/19/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been returned for investigation.The device history review for the product auto endo5 ml lot #73a1900235 investigation did not show issues related to the complaint.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that during laparoscopic cholecystectomy the fourth clip fell at loading.Then another clip got stuck in the applier by which the rotation tab got deformed.Therefore, the device was replaced with a new one.The fallen clip was retrieved so that no clip remained in the patient and no injury to the patient occurred.
 
Manufacturer Narrative
Qn#(b)(4).The customer returned one unit ae05ml autoend05 ml for investigation.This sample is for tc 1900071493 and tc 1900071494.The returned sample was visually examined with and without magnification.Visual examination of the returned device revealed that the jaw spring and one of the feeder tabs were bent and protruding from the tube slots.The top jaw was also bent and there was no clip in the first position of the channel.The damages to the top jaw, jaw spring and feeder would prevent the clips from firing properly.Functional inspection could not be performed due to the observed damages.However, the sample was disassembled to inspect the internal components.It was that the clips were out of position and stacking on one another.The yoke was also broken at the pin position due to the clip stacking.One of the tabs in the channel box was bent.The sample was returned with 7 clips remaining in the channel, indicating that 8 clips were fired by the end user.The observed damages prevented the clips from loading properly.It appears that the top jaw and the channel box tab were damaged during use since multiple clips were able to fire from the device.If the damages were present prior to use, then no clips would have been able to fire from the device.The damage to the top jaw caused the jaw spring to become disengaged from the channel pivot holes.Upon further attempts to fire the device, the jaw spring became bent.The damage to the channel box tab caused restricted movement of the feeder which led to the feeder tab getting bent and the clip stack.Therefore, based upon the observed damages, unintentional user error caused or contributed to this event.The ifu for this product, l06072, was reviewed as a part of this complaint investigation.The ifu for this product states, "mishandling of appliers may result in improper load and/or closure of the ligating clip." a corrective action is not required at this time as the condition of the sample received indicates that unintentional user error caused or contributed to this event.The reported complaint of "clip fell from applier" was confirmed based upon the sample received.The sample was returned with the jaw spring and one of the feeder tabs were bent and protruding from the tube slots.The top jaw was also bent and there was no clip in the first position of the channel.The observed damages would prevent the clips from firing properly.The sample was returned with 7 clips remaining in the channel, indicating that 8 clips were fired by the end user.The sample was disassembled to inspect the internal components.It was that the clips were out of position and stacking on one another.The yoke was also broken at the pin position due to the clip stacking.One of the tabs in the channel box was bent.It appears that the top jaw and the channel box tab were damaged during use since multiple clips were able to fire from the device.If the damages were present prior to use, then no clips would have been able to fire from the device.The damage to the top jaw caused the jaw spring to become disengaged from the channel pivot holes.Upon further attempts to fire the device, the jaw spring became bent.The damage to the channel box tab caused restricted movement of the feeder which led to the feeder tab getting bent and the clip stack.At the time of manufacturing assembly, the autoend05 is 100% inspected for proper clip loading and closure.It is unlikely that this type of damage was present at the time of manufacturing.A device history record review was performed on the device with no evidence to suggest a manufacturing related cause.Therefore, based upon the observed damages, unintentional user error caused or contributed to this event.
 
Event Description
It was reported that during laparoscopic cholecystectomy the fourth clip fell at loading.Then another clip got stuck in the applier by which the rotation tab got deformed.Therefore, the device was replaced with a new one.The fallen clip was retrieved so that no clip remained in the patient and no injury to the patient occurred.
 
Manufacturer Narrative
(b)(4).After an additional medical review, a determination was made to re-classify the complaint as a malfunction.Complaint (b)(4) is being reported as a malfunction.There was no serious injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AUTO ENDO5 ML
Type of Device
CLIP, IMPLANTABLE
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
MDR Report Key8992272
MDR Text Key157406289
Report Number3003898360-2019-01079
Device Sequence Number1
Product Code FZP
Combination Product (y/n)N
PMA/PMN Number
K152081
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 08/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/06/2022
Device Catalogue NumberAE05ML
Device Lot Number73A1900235
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/23/2019
Date Manufacturer Received10/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-