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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK MITEK VAPR COOL PULSE ELECTRODE ELECTROSURGICAL: CUTTING AND COAGULATION

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DEPUY MITEK MITEK VAPR COOL PULSE ELECTRODE ELECTROSURGICAL: CUTTING AND COAGULATION Back to Search Results
Model Number 228147
Device Problem Tip breakage
Event Date 05/31/2011
Event Type  Malfunction  
Event Description

Our rep is reporting to us that during an arthroscopic shoulder repair, a portion of the distal tip, or, some foreign matter from a vapr cool pulse electrode broke or came off of the device into the patient's joint space. The fragment was easily retrieved and the procedure was concluded successfully without further issue or harm to the patient.

 
Manufacturer Narrative

Mitek is at this point in time in the information gathering mode. When all that can be had, is had and thoroughly investigated and evaluated, those results will be the subject matter in a follow-up report.

 
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Brand NameMITEK VAPR COOL PULSE ELECTRODE
Type of DeviceELECTROSURGICAL: CUTTING AND COAGULATION
Manufacturer (Section D)
DEPUY MITEK
325 paramount drive
quality department
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK
325 paramount drive
na
raynham MA 02767
Manufacturer Contact
arthur frigault
325 paramount drive
quality department
raynham , MA 02767
8003824682
MDR Report Key2115418
Report Number1221934-2011-00230
Device Sequence Number1
Product CodeGEI
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 05/31/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/07/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number228147
Device Catalogue Number228147
Device LOT Number1101097
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/01/2011
Is The Reporter A Health Professional? Yes
Distributor Facility Aware Date05/31/2011
Event Location Hospital
Date Report TO Manufacturer05/31/2011
Date Manufacturer Received05/31/2011
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Type of Device Usage Invalid Data

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