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

Catalog Number AE05ML

Device Problems Unintended Ejection (1234); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto endo5 ml, lot #73a1900874.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 laparoscopic assisted distal gastrectomy, clips were able to load into the jaws properly at first.However, one clip was not positioned in the jaws due to some foreign material on the jaws' tip, and the clip fell from the applier in the patient.After removing the fallen clip from the patient, the user tried to load another clip into the jaws, but the clip was unable to load into the jaws properly and the clip fell from the applier again.Then, the user tried to load clips outside of the patient, but the same issue occurred.The ae05ml was replaced by a new one.Some clips were fell from the applier in the patient's body, but they were all removed.No patient injury occurred.

Manufacturer Narrative

(b)(4).The customer returned one unit ae05ml autoend05 ml for investigation.This sample is for tc 1900069859 and tc 1900070228.The returned sample was visually examined with and without magnification.Visual examination of the returned device revealed that 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 properly load into the jaws as it was unable to latch onto the bottom jaw.Upon further examination, it was noticed that there was a buildup of biological material in the bottom jaw.The buildup was manually removed and another attempt was made to fire the device.This time, a clip was able to properly load into the jaws of the applier and was successfully applied to over-stressed tubing.This was repeated with the same result for the remaining clips.The device was returned with 7 clips remaining in the channel, indicating that 8 clips were fired by the end user.The root cause of this complaint issue is the buildup of biological material in the bottom jaw.There were no functional issues found with the device itself.Therefore, based on the condition of the returned sample, unintentional user error caused or contributed to this event.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." a corrective action is not required at this time as the condition of the sample received indicates that unintentional user error caused or contributed to this event.The reported complaint of "clip fell from applier" was confirmed based upon the sample received.One device was returned with 7 clips remaining in the channel, indicating that 8 clips were fired by the end user.Upon functional inspection, it was found that a buildup of biological material was stuck in the bottom jaw which prevented the first clip tested from properly loading.Once the buildup was removed, the remaining clips were able to fire properly.There were no functional issues found with the device.Since the first clip was unable to load due to the buildup of biological material in the jaw, unintentional user error caused or contributed to this event.

Event Description

It was reported that during laparoscopic assisted distal gastrectomy, clips were able to load into the jaws properly at first.However, one clip was not positioned in the jaws due to some foreign material on the jaws' tip, and the clip fell from the applier in the patient.After removing the fallen clip from the patient, the user tried to load another clip into the jaws, but the clip was unable to load into the jaws properly and the clip fell from the applier again.Then, the user tried to load clips outside of the patient, but the same issue occurred.The ae05ml was replaced by a new one.Some clips were fell from the applier in the patient's body, but they were all removed.No patient injury occurred.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8773391
• MDR Text Key: 150576282
• Report Number: 3003898360-2019-00874
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/20/2019

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: 01/27/2022
• Device Catalogue Number: AE05ML
• Device Lot Number: 73A1900874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Initial Date Manufacturer Received: 06/20/2019
• Initial Date FDA Received: 07/09/2019
• Supplement Dates Manufacturer Received: 08/05/2019
• Supplement Dates FDA Received: 08/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1