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

Catalog Number AE05ML

Device Problems Failure to Advance (2524); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto endo5 ml, lot #73l1800729.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 cholecystectomy, a clip fell at loading.Then, another clip got stuck in the applier and the rotation tab was deformed.Therefore, the device was replaced with a new one to complete the operation.The fallen clip was retrieved, and the deformed rotation tab did not touch the patient body.

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: 8900979
• MDR Text Key: 154543540
• Report Number: 3003898360-2019-00993
• 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
• Report Date: 07/23/2019

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: 11/25/2021
• Device Catalogue Number: AE05ML
• Device Lot Number: 73L1800729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Initial Date Manufacturer Received: 07/23/2019
• Initial Date FDA Received: 08/16/2019
• Supplement Dates Manufacturer Received: 09/09/2019
• 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