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

Catalog Number 543965

Device Problems Activation, Positioning or Separation Problem (2906); Material Twisted/Bent (2981); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto endo5 ml lot #73h1800501 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 the first incident was on the (b)(6) 2019 when a hemolock applicator ref (b)(4), lot number 73h1800501 failed to deploy correctly and the clips were bent.Another one from the same batch was opened with the same problem, when the scrub nurse attempted to remove the bent clips the tip fell off the applicator.The remaining items with the same batch number have been quarantined and the mhra informed.No patient was injured.

Manufacturer Narrative

(b)(4).After an additional medical review, a determination was made to re-classify the complaint as a malfunction.Complaint number (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: 8910683
• MDR Text Key: 154882053
• Report Number: 3003898360-2019-01004
• 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: 07/26/2019

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: 73H1800501
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/26/2019
• Initial Date FDA Received: 08/20/2019
• Supplement Dates Manufacturer Received: 08/02/2019
• 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