MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK 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 07/16/2014

Event Type  malfunction  

Event Description

Complaint alleges: the applier was not functioning properly and failed to ligate the vessel.The surgeon attempted to reload, but the reloaded clip was not placed in a position where it was fully open at the distal end to enable the surgeon to fit the vessel into the clip for proper and complete ligation.No pt injury reported.

Manufacturer Narrative

Device history record (dhr) review did not show any issues related to this complaint.No corrective actions can be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the defect.Customer complaint cannot be confirmed due to the lack of product sample to perform a proper investigation and determinate the root cause.Mfg will continue to monitor and trend similar complaints.

• Brand Name: HEMOLOK AUTO ENDO5 ML
• Type of Device: APPLIER
• Manufacturer (Section D): TELEFLEX MEDICAL; rtp NC 27709
• Manufacturer Contact: jasmine brown, reg affairs ; po box 12600; durham, NC 27709 ; 9193614124
• MDR Report Key: 4188015
• MDR Text Key: 5096535
• Report Number: 3003898360-2014-00792
• 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,Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 73E1400169
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/19/2014
• Initial Date FDA Received: 10/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1