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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 Problems Activation, Positioning or Separation Problem (2906); Device Fell (4014)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/22/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that: product was used by the doctor for a lap cholecystectomy.As the trigger was pulled to load clip, clip was not coming out.A second clip was loaded and would clip fall out of applier.
 
Event Description
It was reported that: product was used by the doctor for a lap cholecystectomy.As the trigger was pulled to load clip, clip was not coming out.A second clip was loaded and would clip fall out of applier.
 
Manufacturer Narrative
(b)(4).Per dhr the product auto endo5 ml lot # 73d1900710 was manufactured on (b)(6)2019 a total of 288 pieces.Lot was released on (b)(6)2019.Dhr investigation did not show issues related to complaint.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 was returned with its trigger partially engaged and with the rotation tab slightly bent.The sample appears used as there is biological material present on the device.Reference file anp1900075021 for investigation photos.First, the trigger cycle was completed.Functional inspection was then performed on the returned sample by attempting to engage the trigger using hand pressure.Upon engagement of the trigger, an audible ratchet sound could be heard indicating that the internal ratchet ears are intact.The first clip was unable to load properly into the jaws.There was no clip in the next position of the channel.The sample was disassembled to inspect the internal components.It was found that the clips were out of position and stacking on one another in the channel.A broken hook was found in the channel.The sample was received with 7 clips remaining in the channel, indicating that 8 clips were fired by the end user.The clip stacking prevented the clips from loading properly into the jaws.The clip stacking can also cause the clips to break in the channel as observed in this sample.It could not be determined exactly how or when the clips became out of position.A capa has been opened to further investigate this issue.Reference file anp1900075021 for investigation photos.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." the clip stacking prevented the clips from loading properly into the jaws.It could not be determined exactly how or when the clips became out of position.A capa has been opened to further investigate this issue.The reported complaint of "clip not loading and falling out" was confirmed based upon the sample received.One device was returned with the rotation tab bent.Upon functional inspection, the first clip was unable to load properly and there was no clip in the next position.The sample was disassembled and it was found that the clips were out of position and stacking on one another.A broken clip was found in the channel.The clip stacking prevented the clips from loading properly into the jaws.Although the reported complaint issue was confirmed based on functional testing, it could not be determined exactly how or when the clips became out of position.A capa has been opened to further investigate this issue.
 
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Brand Name
AUTO ENDO5 ML
Type of Device
CLIP, IMPLANTABLE
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key9622531
MDR Text Key176965560
Report Number3003898360-2020-00177
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 01/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/29/2022
Device Catalogue NumberAE05ML
Device Lot Number73D1900710
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/06/2020
Date Manufacturer Received03/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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