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

Catalog Number 543965

Device Problems Failure to Advance (2524); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/19/2019

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 reported that the clip was found stuck and loosen after 7 clips were fired, so the clip could not be closed properly.

Manufacturer Narrative

Qn#(b)(4).Per dhr the product auto endo5 ml lot # 73g1800877 was manufactured on 07/30/2018 a total of (b)(4) pieces.Lot was released on 08/10/2018.Dhr investigation did not show issues related to complaint.The customer returned one unit 543965 autoendo5 ml for investigation.The returned sample was visually examined with and without magnification.Visual examination of the returned device revealed that the sample appears used as there is biological material present on the device.Functional inspection was performed on the returned sample by attempting to engage the trigger using hand pressure.Upon engagement of the trigger, no audible ratchet sound could be heard indicating that the internal ratchet ears are broken.The first clip was unable to properly load into the jaws of the applier as it was unable to latch onto the bottom jaw.Upon further examination, it was noticed that there was a buildup of biological material in the bottom jaw.The buildup was manually removed , and another attempt was made to fire the device.This time, a clip was able to properly load into the jaws of the applier and was successfully applied to over-stressed tubing.This was repeated with the same result for the remaining clips.The device was disassembled to inspect the internal components.Upon disassembly, it was found that the lubrication on the ratchets were not applied properly and that there was hardly any lubrication present on the ratchets.The mis-application and lack of lubrication on the ratchet caused there to be an excess amount of force on the ratchet ears and trigger whenever the trigger was engaged.This resulted in the ratchet ears breaking.The device was returned with 11 clips remaining in the channel, indicating that 4 clips were fired by the end user.Although the remaining clips were able to fire properly after the buildup of biological material was removed, the broken ratchet could cause the clips to become out of position and prevent the clips from properly loading.The ratchet ears broke due to mis-application and lack of lubrication.The lubrication not being applied properly is related to the manufacturing process.Nc 60043527 has already been opened as a result of this issue.Corrective actions have been put in place to improve the manufacturing process and to help prevent the mis-application of the lubrication from recurring.The received sample was manufactured prior to the corrective actions being put in place.The lubrication not being applied properly is an issue related to the manufacturing process.A nonconformance has already been opened as a result of this issue.Corrective actions have been put in place to improve the manufacturing process and to help prevent the mis-application of the lubrication from recurring.The received sample was manufactured prior to the corrective actions being put in place.The reported complaint of "clip stuck" was confirmed based upon the sample received.One device was received.Upon functional inspection, a buildup of biological material was found in the bottom jaw which prevented the first clip tested from loading properly.Once the buildup was removed, the remaining clips were able to fire properly.The sample was disassembled , and it was found that the lubrication on the ratchets were not applied properly.The mis-application and lack of lubrication caused there to be an excess amount of force on the ratchet ears and trigger whenever the trigger was engaged.This resulted in the ratchet ears breaking.Although the remaining clips were able to fire properly after the buildup of biological material was removed, the broken ratchet could cause the clips to become out of position and prevent the clips from loading properly.The lubrication not being applied properly is an issue related to the manufacturing process.A nonconformance has already been opened as a result of this issue.Corrective actions have been put in place to improve the manufacturing process and to help prevent the mis-application of the lubrication from recurring.The received sample was manufactured prior to the corrective actions being put in place.

Event Description

It was reported that reported that the clip was found stuck and loosen after 7 clips were fired, so the clip could not be closed properly.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8623787
• MDR Text Key: 145503574
• Report Number: 3003898360-2019-00631
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K021808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2021
• Device Catalogue Number: 543965
• Device Lot Number: 73G1800877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Date Manufacturer Received: 07/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1