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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 04/23/2021
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).The device history review for the product auto endo5 ml lot# 73f1900184 investigation did not show issues related to the complaint.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
A clip was loaded in closed condition during an operation.Although the user tried to load several times, the same issue occurred.Therefore, the device was replaced with a new one to complete the operation.No clip fell/remained in the patient.
 
Event Description
A clip was loaded in closed condition during an operation.Although the user tried to load several times, the same issue occurred.Therefore, the device was replaced with a new one to complete the operation.No clip fell/remained in the patient.
 
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 was biological material around the jaws.The device was returned with its trigger partially engaged.There was also a clip that was improperly loaded into the jaws.In order to perform functional inspection on the sample, the improperly loaded clip was manually removed from the device.Then an attempt to complete the trigger cycle was made by applying hand pressure to the trigger.Upon engagement of the trigger, no audible ratchet sound was heard indicating that the internal ratchet ears were broken.The next clip did not load properly into the jaws.The sample was disassembled to inspect the internal components.Upon disassembly, it was confirmed that both ratchet ears were broken.The ratchets on each side of the handle frame appeared to be bent.Only two clips were returned in the device indicating that 13 clips were fired by the end user.Although clip stacking could not be confirmed, the broken ratchet likely caused the clips to become out of position and prevented the clips from properly loading into the jaws.This could cause the clips to not be completely open when attempting to fire.It could not be determined what exactly caused the ratchet ears to break.A capa has been opened to further investigate this issue.Multiple root causes have been identified for clip stacking issues, centered around design and manufacturing related root causes.Additionally, user error can contribute to clip stacking issues.Corrective actions are being implemented via the capa.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 capa has been opened to further investigate this issue.Multiple root causes have been identified for clip stacking issues, centered around design and manufacturing related root causes.Additionally, user error can contribute to clip stacking issues.Corrective actions are being implemented via the capa.The reported complaint of "clip(s) not opening" was confirmed based upon the sample received.The device was returned with two clips remaining and its trigger partially engaged.Upon functional inspection, it was found that the clips were not able to properly load into the jaws of the device.The sample was disassembled that it was found that the internal ratchet ears were both broken.The ratchets on each side of the handle frame were also bent.Although clip stacking could not be confirmed, the broken ratchet ears likely caused the clips to become out of position and stack on one another.This could cause the clips to not be completely open when attempting to fire.A capa has been opened to further investigate this issue.Multiple root causes have been identified for clip stacking issues, centered around design and manufacturing related root causes.Additionally, user error can contribute to clip stacking issues.Corrective actions are being implemented via the capa.
 
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Brand Name
AUTO ENDO5 ML
Type of Device
CLIP, IMPLANTABLE
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key11820515
MDR Text Key250836187
Report Number3003898360-2021-00471
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 05/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2021
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 Manufacturer05/17/2021
Date Manufacturer Received06/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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