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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL AUTO ENDO5 ML; CLIP, IMPLANTABLE
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TELEFLEX MEDICAL AUTO ENDO5 ML; CLIP, IMPLANTABLE Back to Search Results
Model Number IPN010797
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/28/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device history review for the product auto endo5 ml lot #73f1900184 investigation did not show issues related to the complaint.
 
Event Description
It was reported that a clip was not loaded into the jaws properly when the user squeezed the handle during an operation.The user squeezed the handle again from that state, then the clip closed.Therefore, the applier was replaced with a new one to complete the operation.
 
Event Description
It was reported that a clip was not loaded into the jaws properly when the user squeezed the handle during an operation.The user squeezed the handle again from that state, then the clip closed.Therefore, the applier was replaced with a new one to complete the operation.
 
Manufacturer Narrative
(b)(4).The customer returned one unit ae05ml autoend05 ml for investigation.The returned sample was visually examined with and without mag nification.Visual examination of the returned device revealed that the sample appears used as there is biological material present on the device.Functional inspection was performed on the returned sample by attempting to engage the trigger using hand pressure.Upon engagement of the trigger, an audible ratchet sound was heard indicating that the internal ratchet ears are intact.The first clip was able to properly load into the jaws of the applier and was successfully applied to over-stressed surgical tubing.The remaining clips were also able to be successfully applied to over-stressed surgical tubing.The sample was received with 9 clips remaining in the channel indicating that 6 clips were fired by the end user.No defects or anomalies were observed.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 reported complaint could not be confirmed for the sample that was returned.The reported complaint of "clip(s) not loading properly" was not confirmed based upon the sample received.One device was returned.Upon functional inspection, no problems were found as clips could be loaded into the jaws and close with no issues.The device was received with 9 clips remaining in the channel indicating that the end user fired 6 clips.All of the clips were successfully applied to over-stressed surgical tubing.A device history record review was performed on the device with no evidence to suggest a manufacturing related cause.No functional issues were found with the returned device.
 
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Brand Name
AUTO ENDO5 ML
Type of Device
CLIP, IMPLANTABLE
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key11992713
MDR Text Key255991805
Report Number3003898360-2021-00562
Device Sequence Number1
Product Code FZP
UDI-Device Identifier14026704553126
UDI-Public14026704553126
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
Type of Report Initial,Followup
Report Date 06/04/2021
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? Yes
Device Operator Health Professional
Device Expiration Date06/04/2022
Device Model NumberIPN010797
Device Catalogue NumberAE05ML
Device Lot Number73F1900184
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/17/2021
Initial Date Manufacturer Received 06/04/2021
Initial Date FDA Received06/14/2021
Supplement Dates Manufacturer Received06/25/2021
Supplement Dates FDA Received07/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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