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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK VAPR S90 ELECTRODEELECTROSURGICAL, CUTTING & COAGULATING

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DEPUY MITEK VAPR S90 ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATING   Back to Search Results
Model Number 225370
Device Problem Unknown (for use when the device problem is not known)
Event Date 12/02/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Our affiliate is reporting that during an arthroscopic shoulder repair, the s90 electrode shorted repeatedly, causing some nerve stimulation at the deltoid area. At this point in time, the surgeon chose to complete the procedure open. The repair was concluded successfully without further incident.

 
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 NameVAPR S90 ELECTRODE
Type of DeviceELECTROSURGICAL, CUTTING & COAGULATING
Manufacturer (Section F)
DEPUY MITEK
325 paramount drive
Manufacturer (Section D)
DEPUY MITEK
325 paramount drive
Manufacturer (Section G)
DEPUY MITEK
325 paramount drive
raynham MA 02767
Manufacturer Contact
arthur frigault
(508) 977 -3856
Device Event Key1609883
MDR Report Key1564348
Event Key1489237
Report Number1221934-2009-00511
Device Sequence Number1
Product CodeGEI
Report Source Manufacturer
Source Type Company Representative,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 12/02/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/22/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number225370
Device Catalogue Number225370
Device LOT NumberM0905095
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/02/2009
Device Age na
Event Location Hospital
Date Report TO Manufacturer12/02/2009
Date Manufacturer Received12/02/2009
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 12/22/2009 Patient Sequence Number: 1
#TreatmentTreatment Date
UNK
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