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

Catalog Number 544965T

Device Problems Premature Activation (1484); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/03/2015

Event Type  malfunction  

Event Description

Alleged event: clips fell off, into the patient.Clips were retrieved by a grasper.The patient's condition was reported as fine.

Manufacturer Narrative

Qn#: (b)(4).The device sample has not been returned to the mfr for investigation at the time of this report.The mfr will continue to monitor and trend related events.

• Brand Name: HEMOLOK TAKEAPART ML 5MM ENDO APPLIER
• Type of Device: APPLIER
• Manufacturer (Section D): TELEFLEX MEDICAL; rtp NC
• Manufacturer (Section G): KMEDIC EUROPE GMBH,; pilling weck, gansacker 36; tuttlingen 7853 2; GM 78532
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 4651064
• MDR Text Key: 5617746
• Report Number: 3005236665-2015-00005
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/13/2015

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
• Device Lot Number: P1400430
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/13/2015
• Initial Date FDA Received: 03/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Patient Sequence Number: 1