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

Catalog Number AE05ML

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/02/2020

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 there was a metallic filament on the side of the jaws.Then the clip came out broken, one part was missing and therefore the clip could not close.The metallic filament was gone but from now on all the clips came out closed from the applier.Clinical consequences: the 2 failures were observed during procedure, but the applier was not used due to the failures.

Event Description

It was reported that there was a metallic filament on the side of the jaws.Then the clip came out broken, one part was missing and therefore the clip could not close.The metallic filament was gone but from now on all the clips came out closed from the applier.Clinical consequences: the 2 failures were observed during procedure, but the applier was not used due to the failures.

Manufacturer Narrative

Qn#(b)(4).Per dhr the product auto endo5 ml lot # 73f1900474 was manufactured on 06/18/2019 a total of (b)(4) pieces.Lot was released on 06/24/2019.Dhr investigation did not show issues related to complaint.The customer returned one unit ae05ml autoend05 ml for investigation.The sample applies to tcs (b)(4) & (b)(4).The returned sample was visually examined with and without magnification.Visual examination of the returned device revealed that the sample was returned with its rotation tab bent and no clip in the first position in the channel.The sample appears used as there is biological material present on the device.Reference file (b)(4) for investigation photos.Functional inspection was performed on device.Upon engagement of the trigger, no audible ratchet sound was heard indicating that the internal ratchet ears are broken.No clip fired.A few more attempts were made, but no clips fired.The sample was disassembled to inspect the internal components.Upon disassembly, it was found that no clips were remaining in the channel.No further damages were observed.The bent rotation tab is an indication that the clips were out of position and stacking on one another in the channel.No "metallic filament" was loose near the jaws.It is possible that the "metallic filament" referred to by the customer is the bent rotation tab.The sample was received with 0 clips remaining in the channel indicating that all 15 clips were fired by the end user.The broken ratchet caused the clips to become out of position and caused the rotation tab to bend.It could not be determined what exactly caused the ratchet ears to break.A capa has been previously opened to further investigate loading and feeding issues.Reference file (b)(4)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.".The broken ratchet appears to have caused a clip stack to occur which resulted in the rotation tab getting bent.It could not be determined what exactly caused the ratchet ears to break but a capa has been previously opened to further investigate loading and feeding issues.The reported complaint of "clip closed in the applier" was confirmed based upon the sample received.The sample applies for tcs (b)(4) & (b)(4).One sample was returned with its rotation tab bent which is an indication that the clips were out of position and stacking on one another in the channel.Additionally, the internal ratchet ears were broken.The broken ratchet appears to have caused a clip stack to occur which resulted in the rotation tab getting bent.No "metallic filament" was loose near the jaws.It is possible that the "metallic filament" referred to by the customer is the bent rotation tab, but this could not be confirmed.The sample was received with 0 clips remaining in the channel indicating that all 15 clips were fired by the end user.Although the reported complaint was confirmed based on functional testing, it could not be determined what exactly caused the ratchet ears to break.A capa has been previously opened to further investigate loading and feeding issues.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9592769
• MDR Text Key: 175847351
• Report Number: 3003898360-2020-00143
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2022
• Device Catalogue Number: AE05ML
• Device Lot Number: 73F1900474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Initial Date Manufacturer Received: 01/13/2020
• Initial Date FDA Received: 01/15/2020
• Supplement Dates Manufacturer Received: 02/26/2020
• Supplement Dates FDA Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1