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

Catalog Number AE05ML

Device Problems Mechanical Jam (2983); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 was returned with no clip in the first position of the channel.The sample appears used as there is biological material present on the device.Dimensional inspection was not required as a part of this complaint investigation.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 was heard indicating that the internal ratchet ears were broken.No clip fired on the first attempt.Multiple attempts were made with the same result.The sample was disassembled to inspect the internal components.The sample was returned with no clips remaining in the channel, indicating that all 15 clips were fired by the end user.One of the feeder tabs was severely bent.It appears that the broken ratchet caused the clips to become out of position and stack on one another in the channel.The clip stacking caused the device to jam.Further attempts to fire the device caused the observed damage to the feeder.Other remarks: the broken ratchet prevented the clips from properly loading into the jaws.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 device history review for the product auto endo5 ml investigation did not show issues related to complaint.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 prevented the clips from loading properly.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 fell from applier" was confirmed based upon the sample received.One sample was returned with no clips remaining indicating that all 15 clips were fired by the end user.

Event Description

It was reported that, the clip will slip away, and the applier cannot fire.Note: prior to use on a patient during inspection/functional testing.Additional information: after receiving the samples, the qa team confirmed that the samples appears to be used as there is biological material on all of them.The customer reported that the patient's condition is stable and the procedure was done by other ligation clip.No clips fell inside the patient; the clip got stuck in the applier.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 9967681
• MDR Text Key: 188199856
• Report Number: 3003898360-2020-00387
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K152081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/13/2020

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: 05/20/2022
• Device Catalogue Number: AE05ML
• Device Lot Number: 73E1900523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2020
• Initial Date FDA Received: 04/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1