MAUDE Adverse Event Report: TELEFLEX MEDICAL AUTO ENDO5 ML; APPLIER

Catalog Number 543965

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/10/2014

Event Type  malfunction  

Event Description

Alleged event: the surgeon could not place clips on the cystic duct due to a malfunction with the applier, clips fell into the patient, but were easily retrieved.The patient's condition was reported as fine.

Manufacturer Narrative

The device sample was received by manufacturer.The investigation has not been submitted at the time of this report.

• Brand Name: AUTO ENDO5 ML
• Type of Device: APPLIER
• Manufacturer (Section D): TELEFLEX MEDICAL; tecate ; MX
• Manufacturer (Section G): PROLONGACION MISION EUSEBIO
• Manufacturer Contact: effie jeferson, rn ; po box 12600; durham, NC 27709 ; 9194332672
• MDR Report Key: 4029931
• MDR Text Key: 22003165
• Report Number: 3003898360-2014-00475
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 543965
• Device Lot Number: 73E1400170
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/21/2014
• Date Manufacturer Received: 07/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Patient Sequence Number: 1