MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK TAKEPART ML 5MM ENDO APPLIER

Catalog Number 544965T

Device Problems Activation, Positioning or Separation Problem (2906); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2014

Event Type  malfunction  

Event Description

It was reported that "first clip was successfully placed.The second clip did not want to click.After careful maneuvering, a small piece fell out of the jaw." no pt injury reported.

Manufacturer Narrative

(b)(4).The device was not received by the mfr at the time of this report.Mfr will continue to monitor and trend relating complaints.

• Brand Name: HEMOLOK TAKEPART ML 5MM ENDO APPLIER
• Type of Device: ENDO APPLIER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): KMEDIC EUROPE GMBH; gaensaecker 36; tuttlingen 7853 2; GM 78532
• Manufacturer Contact: jasmine brown, regulatory affairs ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 4344484
• MDR Text Key: 5177340
• Report Number: 3005236665-2014-00015
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/11/2014

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: Other
• Device Catalogue Number: 544965T
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/11/2014
• Initial Date FDA Received: 12/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Patient Sequence Number: 1