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

Catalog Number AE05ML

Device Problems Activation, Positioning or Separation Problem (2906); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto endo5 ml, lot #73l1800543.Investigation did not show issues related to the complaint.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the doctor tried to load the fourth clip into the jaws, but the clip got stuck in the applier.And the next clip coming out from the applier got deformed and fell from the applier into the patient.The clip that fell from the applier was removed and no patient injury occurred.

Manufacturer Narrative

Qn# (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.Functional inspection was performed on the returned sample by attempting to engage the trigger using hand pressure.Upon engagement of the trigger, an audible ratchet sound could be heard indicating that the internal ratchet ears are intact.Resistance was felt upon engaging the trigger.The first clip protruded from the channel.The next clip was also out of position in the channel.On the next attempt, the next clip was unable to load properly as the clip was to the side of the pusher head (distal end of feeder).The sample was disassembled to inspect the internal components.The proximal end of the feeder was bent.The sample was received with 3 clips remaining in the channel, indicating that 12 clips were fired by the end user.The clip misloads, clips being out of position and the proximal end of the feeder being bent are indications that the clips were out of position and stacking on one another in the channel.The clip stacking prevented the clips from loading properly into the jaws.It could not be determined exactly how or when the clips came out of position.A capa has been opened to further investigate this issue.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 reported complaint of "clip stuck in applier" was confirmed based upon the sample received.One device was returned with no clip in the first position of the channel.Upon functional inspection, the first clip protruded from the channel.The next clip was also out of position in the channel.On the next attempt, the next clip was unable to load properly as the clip was to the side of the pusher head (distal end of feeder).The sample was disassembled , and the proximal end of the feeder was bent.The clip misloads, clips being out of position and the proximal end of the feeder being bent are indications that the clips were out of position and stacking on one another in the channel.The clip stacking prevented the clips from loading properly into the jaws.Although the reported complaint issue was confirmed based on functional testing, it could not be determined exactly how or when the clips came out of position.A capa has been opened to further investigate this issue.

Event Description

It was reported that the doctor tried to load the fourth clip into the jaws, but the clip got stuck in the applier.And the next clip coming out from the applier got deformed and fell from the applier into the patient.The clip that fell from the applier was removed and no patient injury occurred.

Manufacturer Narrative

(b)(4).After an additional medical review, a determination was made to re-classify the complaint as a malfunction.Complaint number (b)(4) is being reported as a malfunction.There was no serious injury.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8911286
• MDR Text Key: 154903148
• Report Number: 3003898360-2019-01013
• 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,Followup
• Report Date: 07/29/2019

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: 11/18/2021
• Device Catalogue Number: AE05ML
• Device Lot Number: 73L1800543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Initial Date Manufacturer Received: 07/29/2019
• Initial Date FDA Received: 08/20/2019
• Supplement Dates Manufacturer Received: 09/16/2019; 09/16/2019
• Supplement Dates FDA Received: 09/19/2019; 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention