MAUDE Adverse Event Report: KMEDIC GMBH, TELEFLEX MEDICAL HEMOLOK TAKEAPART ML 5MM ENDO APPLIER; TAKEAPART APPLIER

Catalog Number 544965T

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2014

Event Type  malfunction  

Event Description

Reported event described as: alleged issue: it was reported that during a laparoscopic nephrectomy, at the time a clip was using the plier, which broke in the abdominal cavity.It required removing the broken pieces of pliers with the trocar.No pt injury reported.

Manufacturer Narrative

The device sample was not received by the manufacturer at the time of this report.

• Brand Name: HEMOLOK TAKEAPART ML 5MM ENDO APPLIER
• Type of Device: TAKEAPART APPLIER
• Manufacturer (Section D): KMEDIC GMBH, TELEFLEX MEDICAL; pilling weck ; GM
• Manufacturer (Section G): KMEDIC EUROPE GMBH; pilling weck
• Manufacturer Contact: jasmine brown ; po box 12600; durham, NC 27709 ; 9193614124
• MDR Report Key: 3908279
• MDR Text Key: 15118328
• Report Number: 3005236665-2014-00009
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 544965T
• Device Lot Number: P1341669
• Date Manufacturer Received: 05/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1