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 12/17/2019

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 the clip applier closed prematurely.

Manufacturer Narrative

(b)(4).Per dhr the product auto endo5 ml lot # 73k1800132 was manufactured on 10/04/2018 a total of 288 pieces.Lot was released on 10/15/2018.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 no clip in the first position of the channel.The channel box was bent inwards and the rotation tab was also bent.The damage to the channel box would prevent clips from firing from the device.The sample appears used as there is biological material present on the device.Reference file (b)(4) for investigation photos.First, the trigger cycle was completed.Functional inspection could not be performed due to the damage to the channel box.However, the sample was disassembled to inspect the internal components.It was found that both jaws were bent.The pivot holes in the channel for the jaws were deformed.The sample was returned with 0 clips remaining in the channel, indicating that all 15 clips were fired by the end user.The bent rotation tab is an indication that the clips were out of position and stacking on one another in the channel.It appears that the jaws and the channel box were damaged during use since multiple clips were able to fire from the device.If the channel box was damaged prior to use, then no clips would have been able to fire from the device.The damage to the channel box caused restricted movement of the feeder which led to the clip stack.Therefore, based upon the observed damage, unintentional user error caused or contributed to this event.Reference file anp1900074291 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 "clip applier closed prematurely" was confirmed based upon the sample received.The sample was returned with its channel box bent inwards, rotation tab bent, and both jaws bent.The damage to the channel box would prevent clips from firing from the device.The sample was returned with 0 clips remaining in the channel, indicating that all 15 clips were fired by the end user.The jaws and the channel box were damaged during use since multiple clips were able to fire from the device.If the channel box was damaged prior to use, then no clips would have been able to fire from the device.The damage to the channel box caused restricted movement of the feeder which led to the clip stack.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.Therefore, 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

It was reported that the clip applier closed prematurely.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9491616
• MDR Text Key: 173229122
• Report Number: 3003898360-2019-01573
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2021
• Device Catalogue Number: AE05ML
• Device Lot Number: 73K1800132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Initial Date Manufacturer Received: 12/17/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 01/22/2020
• Supplement Dates FDA Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1