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

Catalog Number 543965

Device Problems Failure to Advance (2524); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto endo5 ml lot #73h1800502 investigation did not show issues related to the complaint.The device investigation is pending.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that (b)(6) 2019, the professor in biliary pancreatic surgery of reported that about the fifth clip was stuck and loose during usage on the patient which caused the clip not to be closed properly.Then changing to a new one, but the clip could not open.

Manufacturer Narrative

(b)(4).After an additional medical review, a determination was made to re-classify the complaint as a malfunction.Complaint 3003898360-2019-01047 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: 8932043
• MDR Text Key: 155559496
• Report Number: 3003898360-2019-01047
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K021808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/10/2019

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: 08/15/2021
• Device Catalogue Number: 543965
• Device Lot Number: 73H1800502
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/10/2019
• Initial Date FDA Received: 08/26/2019
• Supplement Dates Manufacturer Received: 08/20/2019
• Supplement Dates FDA Received: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention