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

Catalog Number AE05ML

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/12/2020

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

Surgeon has used device before.But for this case, he experienced after firing 1st clip, 2nd clip was jammed at the jaw and device failed to function as expected.Surgeon aborted device and turned to manual hemolok instead for safety reason but wants investigation report and monetary refund.

Manufacturer Narrative

(b)(4).Per dhr the product auto endo5 ml lot # 73d1900713 was manufactured on 04/30/2019 a total of (b)(4) pieces.Lot was released on 05/10/2019.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 magnification.Visual examination of the returned device revealed that the sample appeared used as there was biological material on the device.Functional inspection was performed by applying hand pressure onto the trigger of the device.Upon engagement of the trigger, no audible ratchet sound was heard indicating that the internal ratchet ears were broken.The first clip did not properly load into the jaws.The clip was removed , and another attempt was made.A second attempt was made , and the next clip was also unable to properly load into the jaws.The sample was disassembled to inspect the internal components.Upon disassembly, the broken ratchet was confirmed.There were no clips remaining in the channel.No further damages were observed.The sample was received with 2 clips remaining in the channel indicating that 13 clips were fired by the end user.The broken ratchet may have caused the clips to become out of position.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.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 may have caused the clips to become out of position.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.The reported complaint of "jamming - clip stuck in jaw area" was confirmed based upon the sample received.Upon functional inspection, it was found that the internal ratchet ears were broken.Clip stacking could not be confirmed; however, the broken ratchet may have caused the clips to become out of position.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.

Event Description

Surgeon has used device before.But for this case, he experienced after firing 1st clip, 2nd clip was jammed at the jaw and device failed to function as expected.Surgeon aborted device and turned to manual hemolok instead for safety reason but wants investigation report and monetary refund.

Event Description

Surgeon has used device before.But for this case, he experienced after firing 1st clip, 2nd clip was jammed at the jaw and device failed to function as expected.Surgeon aborted device and turned to manual hemolok instead for safety reason but wants investigation report and monetary refund.

Manufacturer Narrative

(b)(4).Per dhr the product auto endo5 ml lot # 73d1900713 was manufactured on 04/30/2019 a total of 288 pieces.Lot was released on 05/10/2019.Dhr investigation did not show issues related to complaint.Revision of fmea-08-029 rev 04 was performed and the failure mode is already including it, no update is required.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time due the sample is not available is not possible to determine the source of the defect reported.Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11030594
• MDR Text Key: 222377692
• Report Number: 3003898360-2020-01059
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2020

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: 04/29/2022
• Device Catalogue Number: AE05ML
• Device Lot Number: 73D1900713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 12/18/2020; 01/27/2021
• Supplement Dates FDA Received: 01/07/2021; 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1