MAUDE Adverse Event Report: KMEDIC GMBH HEMOLOK TAKEAPART MIL 5MM ENDO APPLIER; TAKEAPART APPLIER

Model Number 544965T

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2014

Event Type  malfunction  

Event Description

Reported event described as: alleged issue: the clips fell out of the jaw into the pt.The clips were retrieved.No pt injury reported.

Manufacturer Narrative

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

• Brand Name: HEMOLOK TAKEAPART MIL 5MM ENDO APPLIER
• Type of Device: TAKEAPART APPLIER
• Manufacturer (Section D): KMEDIC GMBH; pilling weck; teleflex medical; GM
• Manufacturer (Section G): KMEDIC EUROPE GMBH; filling weck
• Manufacturer Contact: elaine burkle, rn ; po box 12600; durham, NC 27709 ; 9194334957
• MDR Report Key: 3888486
• MDR Text Key: 21445788
• Report Number: 3005236665-2014-00008
• 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,Health Professional,User Facility,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/09/2014

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 Model Number: 544965T
• Device Lot Number: P1245173
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/09/2014
• Initial Date FDA Received: 04/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1