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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 Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/17/2019
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 around 11am est today, the doctor was performing a lap chole with ae05ml.Around 11:30 the general surgery coordinator reported the incident.He said that a part of the jaws broke off inside the patient.The patient is okay and all parts of the device were recovered and saved.
 
Manufacturer Narrative
Qn#(b)(4).Per dhr the product auto endo5 ml lot # 73g1900662 was manufactured on 07/23/2019 a total of (b)(4) pieces.Lot was released on 08/01/2019.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 the bottom jaw missing from the device.The bottom jaw was not returned.The sample appears used as there is biological material present on the device.Reference file (b)(4) for investigation photos.Functional inspection could not be performed due to the condition of the returned sample.However, the device was disassembled in order to inspect the internal components.It was observed that the channel pivot holes for the bottom jaw were damaged.The pivot holes were oblong in shape and the damage appeared to have been caused by a significant side pressure applied to the hole by the bottom jaw.Based on the observed damage, it appears that the bottom jaw was being pulled out of the device which caused the side pressure on the pivot holes.After the pivot holes became damaged, the jaw was easily able to detach from the channel and fall out of the device.No other damages were observed.The sample was returned with 12 clips remaining in the channel indicating that 3 clips were fired by the end user.Reference file anp1900074290 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." 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 "jaw broke off in patient" was confirmed based upon the sample received.The sample was returned with the bottom jaw missing from the device.It was found that the channel pivot holes for the bottom jaw were oblong which appeared to have been caused by a significant side pressure applied to the hole by the bottom jaw.Based on the observed damage, it appears that the bottom jaw was being pulled out of the device which caused the side pressure on the pivot holes.After the pivot holes became damaged, the jaw was easily able to detach from the channel and fall out of the device.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.Based upon the observed damage, unintentional user error caused or contributed to this event.
 
Event Description
It was reported that around 11am est today, the doctor was performing a lap chole with ae05ml.Around 11:30 the general surgery coordinator reported the incident.He said that a part of the jaws broke off inside the patient.The patient is okay and all parts of the device were recovered and saved.
 
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Brand Name
AUTO ENDO5 ML
Type of Device
CLIP, IMPLANTABLE
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key9491704
MDR Text Key173229733
Report Number3003898360-2019-01574
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 health professional,user faci
Type of Report Initial,Followup
Report Date 12/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/22/2022
Device Catalogue NumberAE05ML
Device Lot Number73G1900662
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2020
Date Manufacturer Received02/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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