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

Catalog Number AE05ML

Device Problems Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)

Patient Problems Tissue Damage (2104); No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 03/20/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer returned one-unit ae05ml autoend05 ml for investigation.The sample was reviewed with a rd engineer.The returned sample was visually examined with and without magnification.Visual examination of the returned device revealed that there was no clip in the first position.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 full engagement of the trigger, an audible ratchet sound was heard indicating that the internal ratchet ears were intact.No clip fired.The sample was disassembled in order to inspect the internal components.The sample was returned with 0 clips remaining in the channel, indicating that all 15 clips were fired by the end user.Dimensional inspection was performed on the jog and the jaw tips.However, no issues were observed as the parts were found to be within specifications.Since the sample was returned with no clips remaining, the reported complaint could not be confirmed, and a probable cause could not be determined.The device history review for the product auto endo5 ml lot# 73d1900537 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." other remarks: a corrective action is not required at this time as it could not be determined what caused the complaint issue since no clips were remaining in the returned sample.Dimensional inspection was performed on the jog and the jaw tips and the parts were within specifications.At the time of manufacturing assembly, the autoendo5 is 100% inspected for proper clip loading and closure.The device history record review showed no evidence to suggest a manufacturing related cause.A capa is already open to investigate loading issues associated with (b)(4)/ae05ml.Teleflex will continue to monitor and trend on complaints of this nature.The reported complaint of "clip cut vessel" was not confirmed based upon the sample received.One device was returned.The sample was reviewed with a rd engineer.The device was received with 0 clips remaining in the channel indicating that all 15 clips were fired by the end user.Dimensional inspection was performed on the jog and the jaw tips.However, no issues were observed as the parts were found to be within specifications.At the time of manufacturing assembly, the autoendo5 is 100% inspected for proper clip loading and closure.A device history record review was performed on the autoendo5 with no evidence to suggest a manufacturing related cause.Since there were no clips remaining in the returned device, the reported complaint issue could not be confirmed, and a probable cause could not be determined.Capa (b)(4) is already open to investigate loading issues associated with (b)(4)/ae05ml.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

The report states: surgeon periodically uses ae05ml but he is familiar.On day of incident, 1st piece of ae05ml was opened but nothing came out despite multiple firing.When 2nd piece of the same batch was open, after firing 3 clips and when surgeon wanted to remove applier from peritoneum, he was unable to remove it as the applier was caught together with the clip.Surgeon had no choice but to pull it off and resulted in ripping the vessel.Surgeon had to suture the vessel to stop the bleed.

• 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: 9957268
• MDR Text Key: 187538421
• Report Number: 3003898360-2020-00343
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 03/23/2020

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: 04/21/2022
• Device Catalogue Number: AE05ML
• Device Lot Number: 73D1900537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2020
• Initial Date FDA Received: 04/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2019
• 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
• Patient Outcome(s): Required Intervention