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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 Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/02/2019
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).The device history review for the product auto endo5 ml lot #73l1800541 investigation did not show issues related to the complaint.The device investigation is pending.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that during an extended hysterectomy although several clips were loaded into the jaws properly at first, the next clip got stuck in the applier.The applier was replaced with a new one.No clips fell in the patient.
 
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 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, no audible ratchet sound could be heard indicating that the internal ratchet ears are broken.The first clip was unable to load properly into the jaws as it had its hook broken off.Another attempt was made , and the second clip was also unable to load properly.The sample was disassembled to inspect the internal components.It was confirmed that the ratchet ears were broken.It was found that the clips were out of position and stacking on one another in the channel.The proximal end of the feeder was bent due to the clip stacking.The sample was received with 9 clips remaining in the channel indicating that 6 clips were fired by the end user.The broken ratchet caused the clips to come out of position and prevented the clips from loading properly into the jaws.It could not be determined what exactly caused the ratchet ears to break but a nonconformance has been opened to further investigate this issue.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 broken ratchet caused the clips to come out of position and prevented the clips from loading properly into the jaws.It could not be determined what exactly caused the ratchet ears to break but a nonconformance has been opened to further investigate this issue.The reported complaint of "clip got stuck in applier" was confirmed based upon the sample received.One device was returned.Upon functional inspection, the clips were unable to load properly.The sample was disassembled , and it was found that the clips were out of position and stacking on one another in the channel.The proximal end of the feeder was bent due to the clip stacking.The broken ratchet caused the clips to come out of position and prevented the clips from loading properly into the jaws.It could not be determined what exactly caused the ratchet ears to break but a nonconforemance has been opened to further investigate this issue.
 
Event Description
It was reported that during an extended hysterectomy although several clips were loaded into the jaws properly at first, the next clip got stuck in the applier.The applier was replaced with a new one.No clips fell in the patient.
 
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Brand Name
AUTO ENDO5 ML
Type of Device
CLIP, IMPLANTABLE
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
MDR Report Key8728791
MDR Text Key149091002
Report Number3003898360-2019-00729
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 company representative,foreig
Type of Report Initial,Followup
Report Date 05/31/2019
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 Date11/18/2021
Device Catalogue NumberAE05ML
Device Lot Number73L1800541
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2019
Initial Date Manufacturer Received 05/31/2019
Initial Date FDA Received06/24/2019
Supplement Dates Manufacturer Received07/19/2019
Supplement Dates FDA Received07/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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