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 centering tab bent at the distal end of the channel.The corners of the centering tab were not formed correctly.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 was heard indicating that the internal ratchet ears are intact.The first clip was unable to load properly due to the bent centering tab.The indicator clip fired on the next attempt which indicates that no more clips were remaining.The sample was disassembled in order to inspect the internal components.No further damages were observed.The device was returned with 1 clip remaining in the channel indicating that 14 clips were fired by the end user.The damage to the centering tab prevented the clips from loading properly into the jaws of the applier.It could not be determined exactly how or what caused the centering tab to bend.However, the corners of the centering tab were not formed correctly.It is possible that the malformed corners of the centering tab contributed to the bending of the centering tab.The channel is a purchased part from a supplier.A nonconformance has already been opened as a result of this issue.Corrective actions have been put in place to prevent this issue from recurring.The received sample was manufactured prior to the corrective actions being put in place.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." it could not be determined exactly how or what caused the centering tab to bend.However, the corners of the centering tab were not formed correctly.It is possible that the malformed corners of the centering tab contributed to the bending of the centering tab.The channel is a purchased part from a supplier.A nonconformance has already been opened as a result of this issue.Corrective actions have been put in place to prevent this issue from recurring.The received sample was manufactured prior to the corrective actions being put in place.The reported complaint of "clips loaded in closed condition" was confirmed based upon the sample received.The sample was received with the centering tab bent at the distal end of the channel.The corners of the centering tab were not formed correctly.Upon functional inspection, the one remaining clip was unable to load due to the bent centering tab.It could not be determined exactly how or what caused the centering tab to bend.However, the corners of the centering tab were not formed correctly.It is possible that the malformed corners of the centering tab contributed to the bending of the centering tab.The channel is a purchased part from a supplier.A nonconformance has already been opened as a result of this issue.Corrective actions have been put in place to prevent this issue from recurring.The received sample was manufactured prior to the corrective actions being put in place.

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)(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: 8955467
• MDR Text Key: 156283264
• Report Number: 3003898360-2019-01106
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2022
• Device Catalogue Number: AE05ML
• Device Lot Number: 73A1900236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Initial Date Manufacturer Received: 08/15/2019
• Initial Date FDA Received: 09/03/2019
• Supplement Dates Manufacturer Received: 10/03/2019; 10/03/2019
• Supplement Dates FDA Received: 10/04/2019; 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention