MAUDE Adverse Event Report: TELEFLEX MEDICAL AUTO ENDO5 ML; CLIP, IMPLANTABLE

Catalog Number AE05ML

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2019

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

The report states: device was described as defective; not delivering clips as it should.

Manufacturer Narrative

Qn#(b)(4).Per dhr the product auto endo5 ml lot # 73g1900483 was manufactured on 07/16/2019 a total of (b)(4) pieces.Lot was released on 07/30/2019.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.The bottom jaw was missing from the device and was not returned.The top jaw was also pushed into the outer tube and the jaw spring was disengaged from the jaws.The sample appears used as there is biological material present on the device.Reference file anp1900074316 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 yoke was broken at the pin position.The jaw spring was bent on the side of the top jaw.The channel pivot holes for the jaws were deformed.The clips were also out of position and stacking on one another in the channel.The sample was returned with 8 clips remaining in the channel indicating that 7 clips were fired by the end user.The pivot holes were oblong in shape and the damage appeared to have been caused by a significant side pressure applied by the jaws.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 bottom jaw was easily able to detach from the channel and fall out of the device.Additionally, it appears that the top jaw was pushed against something or was used to pry something.If the device was fired in that condition, it would cause the jaw spring to bend.The damage to the jaws would prevent the clips from loading properly.If a clip misloads and is not cleared prior to loading another clip, the clips can be held up in the loading sequence and cause a clip stacking issue.The clip stacking can cause other components such as the yoke to break.Therefore based upon the observed damaged, unintentional user error caused or contributed to this event.Reference file anp1900074316 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 "clips not loading properly" was confirmed based upon the sample received.The sample was returned with the bottom jaw missing from the device.The top jaw was also pushed into the outer tube and the jaw spring was disengaged from the jaws.Functional inspection could not be performed since the damages to the device would prevent the clips from loading properly.The sample was disassembled.It was found that the channel pivot holes for the jaws were oblong in shape and the damage appeared to have been caused by a significant side pressure applied by the jaws.It appears that the bottom jaw was being pulled out of the device.After the pivot holes became damaged, the bottom jaw was easily able to detach from the channel and fall out of the device.Additionally, it appears that the top jaw was pushed against something or was used to pry something.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.Teleflex will continue to monitor and trend reports of this nature.

Event Description

The report states: device was described as defective; not delivering clips as it should.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9552817
• MDR Text Key: 174519164
• Report Number: 3003898360-2020-00087
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K152081
• Number of Events Reported: 1
• 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 Received: 01/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2022
• Device Catalogue Number: AE05ML
• Device Lot Number: 73G1900483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Date Manufacturer Received: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1