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

Catalog Number 543965

Device Problem Unintended Ejection (1234)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2019

Event Type  malfunction  

Manufacturer Narrative

Qn# (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 hemolock clamp/applier was inserted inside the port for the application of the clips and all the clips fell out of the applier.

Event Description

It was reported that the hemolock clamp/applier was inserted inside the port for the application of the clips and all the clips fell out of the applier.

Manufacturer Narrative

Qn#(b)(4).Per dhr the product auto endo5 ml lot # 73g1800089 was manufactured on 07/09/2018 a total of 288 pieces.Lot was released on 07/27/2018.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 typical.No clip was in the first position in the channel.Functional inspection was performed on the returned sample by attempting to engage the trigger using hand pressure.Upon engagement of the trigger, no ratchet sound could be heard indicating that the internal ratchet ears are broken.No clip fired.Several more attempts were made and no clips fired.The sample was received with 0 clips remaining in the channel indicating that all 15 clips were fired by the end user.Although no clips were remaining to test, the broken ratchet could prevent the clips from properly loading into the jaws.It could not be determined what exactly caused the ratchet ears to break but nc 70018423 has been opened to further investigate this issue.The ifu for this product, l03496, 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 reported complaint of "failure to function" was confirmed based upon the sample received.One device was returned.Upon functional inspection, no clips were remaining in the device.The device was found to have broken internal ratchet ears which could affect the end user's ability to properly load and apply clips.The device was received with 0 clips remaining in the channel indicating that all 15 clips were fired by the end user.It could not be determined what exactly caused the ratchet ears to break but nc 70018423 has been opened to further investigate this issue.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8367637
• MDR Text Key: 137061987
• Report Number: 3003898360-2019-00270
• 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: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2021
• Device Catalogue Number: 543965
• Device Lot Number: 73G1800089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Date Manufacturer Received: 04/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1