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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
Catalog Number AE05ML
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/17/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device history review for the product auto endo5 ml, lot# 73e1900682.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
It was reported that after several proper loading, the clips were not loaded into the jaws properly during a laparoscopic cholecystectomy.Therefore, the device was replaced with a new unit to complete the operation.
 
Event Description
It was reported that after several proper loading, the clips were not loaded into the jaws properly during a laparoscopic cholecystectomy.Therefore, the device was replaced with a new unit to complete the operation.
 
Manufacturer Narrative
Qn# (b)(4).The customer returned one unit ae05ml autoend05 ml for investigation.The returned sample was visually examined with and without magnification.Visual examination of the returned device revealed that the sample was returned with its bottom jaw bent.The sample had a partially engaged trigger with an indicator clip loaded into the jaws.There were no clips remaining in the sample.The sample appeared used as there was biological material present on the device.Functional inspection could not be performed due to the condition of the returned sample.After manual removal of the indicator clip the sample was able to complete the trigger cycle.Although no clips were remaining, the trigger cycle was completed, and it was found that the ratchet was fully intact.The sample was disassembled to inspect all components.Upon disassembly, it was confirmed that the bottom jaw was bent, and the jaw spring was slightly bent.The bent bottom jaw and jaw spring would prevent clips from properly loading and firing since the jaws are misaligned.However, it cannot be determined what caused the jaw to bend.Based upon the observed damage, 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 "clips not loading properly" was confirmed based upon the sample received.The sample was returned with the bottom jaw bent and the jaw spring slightly bent.The bending indicates that there was a significant side load applied to the jaws that caused the bottom jaw to bend.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 defect.Therefore, based upon the observed damage, unintentional user error caused or contributed to this event.
 
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Brand Name
AUTO ENDO5 ML
Type of Device
CLIP, IMPLANTABLE
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key10478292
MDR Text Key205166158
Report Number3003898360-2020-00700
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
Type of Report Initial,Followup
Report Date 08/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/26/2022
Device Catalogue NumberAE05ML
Device Lot Number73E1900682
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/01/2020
Date Manufacturer Received10/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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