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

Catalog Number AE05ML

Device Problems Difficult to Open or Close (2921); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto endo5 ml lot #73a1900236 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 during an operation a clip was loaded in closed condition.The user tried to load outside the patient's body several times which resulted in the same occurrence.Therefore, the device was replaced with a new one.A clip fell but was retrieved; no clip remained in the patient.

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 its trigger partially engaged and the rotation tab bent.A double feed was observed as two clips were partially loaded incorrectly into the jaws.The second clip was also stuck in the bent rotation tab.First, the partially loaded clips were manually removed , and the trigger cycle was completed.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 was heard.However, the ratchet sound seemed softer than usual.The first clip was able to load properly into the jaws and was successfully applied to over-stressed surgical tubing.There was no clip in the next position of the channel.The sample was disassembled to inspect the internal components.The ratchet ears were found broken.The soft ratchet sound heard during loading of the first clip indicates that one of the ratchet ears was still intact at that time.It appears that after the first clip fired, the second ratchet ear broke.It was also found that the clips were out of position and stacking on one another in the channel.The broken ratchet caused the clips to become out of position and prevented the clips from properly loading into the jaws.The sample was received with 12 clips remaining in the channel indicating that 3 clips were fired by the end user.It could not be determined what exactly caused the ratchet ears to break but a nonconformance 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 broken ratchet prevented the clips from properly loading into the jaws.It could not be determined what exactly caused the ratchet ears to break but a nonconformance has been opened to further investigate this issue.The reported complaint of "clips loaded in closed condition" was confirmed based upon the sample received.One device was returned with the rotation tab bent.A double feed was observed as two clips were partially loaded incorrectly into the jaws.The second clip was also stuck in the bent rotation tab.Upon functional inspection, the first clip was able to load properly into the jaws and was successfully applied to over-stressed surgical tubing.However, there was no clip in the next position of the channel.The sample was disassembled , and it was found that the clips were out of position and stacking on one another.The device was found to have broken internal ratchet ears which caused the clips to become out of position and prevented the clips from loading properly.The device was received with 12 clips remaining in the channel indicating that 3 clips were fired by the end user.It could not be determined what exactly caused the ratchet ears to break but a nonconformance has been opened to further investigate this issue.

Event Description

It was reported that during an operation a clip was loaded in closed condition.The user tried to load outside the patient's body several times which resulted in the same occurrence.Therefore, the device was replaced with a new one.A clip fell but was retrieved; no clip remained in the patient.

Manufacturer Narrative

(b)(4) after an additional medical review, a determination was made to re-classify the complaint as a malfunction.Complaint (b)(64 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: 8955444
• MDR Text Key: 156276441
• Report Number: 3003898360-2019-01107
• 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: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2022
• Device Catalogue Number: AE05ML
• Device Lot Number: 73B1900053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Date Manufacturer Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention