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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 Leak/Splash (1354); Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/22/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device history review for the product auto endo5 ml lot# 73k1800340 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 during laparoscopy-assisted distal gastrectomy, the second clip was loaded in closed condition and the third clip was loaded misaligned.The user replaced the device with a new one to complete the surgery.No clip 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 was returned with its trigger partially engaged and the rotation tab bent.A clip was partially loaded incorrectly into the jaws of the device, as it was observed that the feeder was to the side of the clip.First, the partially loaded clip was manually removed , and 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 next clip was unable to load properly as it was observed that again, the feeder was to the side of the clip.This was repeated with the same result for the following clip.The sample was disassembled to inspect the internal components.Upon disassembly, it was found that the clips were out of position and stacking on one another.The clip stacking could prevent the clips from properly loading into the jaws.The sample was received with 8 clips remaining, including the partially loaded clip, indicating that 7 clips were fired by the end user.It could not be determined exactly how or when the clips came out of position.A nonconformance has been opened to further investigate the clip stacking 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 reported complaint of "clips not loaded properly" was confirmed based upon the sample received.One device was returned with its trigger partially engaged and the rotation tab bent.A clip was partially loaded incorrectly into the jaws of the device, as it was observed that the feeder was to the side of the clip.Upon functional inspection, the next clip was unable to load properly as it was observed that again, the feeder was to the side of the clip.This was repeated with the same result for the following clip.It was found that the clips were out of position and stacking on one another.The clip stacking could prevent the clips from properly loading into the jaws.The sample was received with 8 clips remaining, including the partially loaded clip, indicating that 7 clips were fired by the end user.It could not be determined exactly how or when the clips came out of position.A nonconformance has been opened to further investigate the clip stacking issue.
 
Event Description
It was reported that during laparoscopy-assisted distal gastrectomy, the second clip was loaded in closed condition and the third clip was loaded misaligned.The user replaced the device with a new one to complete the surgery.No clip 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 Key8497220
MDR Text Key141385099
Report Number3003898360-2019-00393
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 03/22/2019
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 Date10/09/2021
Device Catalogue NumberAE05ML
Device Lot Number73K1800340
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/29/2019
Initial Date Manufacturer Received 03/22/2019
Initial Date FDA Received04/09/2019
Supplement Dates Manufacturer Received05/07/2019
Supplement Dates FDA Received05/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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