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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEKMITEK VAPR CP ELECTRODEELECTROSURGICAL: CUTTING AND COAGULATING

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DEPUY MITEK MITEK VAPR CP ELECTRODE ELECTROSURGICAL: CUTTING AND COAGULATING   Back to Search Results
Catalog Number 228147
Event Date 05/04/2012
Event Type  Injury   Patient Outcome  Required Intervention
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.

 
Event Description

Our rep. Is reporting to us that during an arthroscopic shoulder procedure the surgeon was manhandling / leveraging an electrode against the patient's skin in order to get a better angle of approach while performing a sad. At the end of the procedure they noted that the patient had sustained some portal burns at the area that was being pressed with the electrode shaft; skin bubbling. Complaint device discarded and no lot number could be supplied.

 
Manufacturer Narrative

(b)(6) days have passed since this issue was reported to mitek, and to date, despite outreaches, no additional information other than what was originally reported has been received and nothing is being returned. We cannot tell anything from this; we cannot discern the root or underlying cause for the reported issue. At this point in time, no further action is warranted. However, this file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue. Also, mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

 
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Brand NameMITEK VAPR CP ELECTRODE
Type of DeviceELECTROSURGICAL: CUTTING AND COAGULATING
Manufacturer (Section F)
DEPUY MITEK
325 paramount drive
quality department
raynham MA 02767
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
(800) 382 -4682
Device Event Key2619569
MDR Report Key2590459
Event Key2487152
Report Number1221934-2012-00146
Device Sequence Number1
Product CodeGEI
Report Source Manufacturer
Source Type User facility,Health Professional
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Followup,Initial
Report Date 05/04/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/29/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number228147
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Distributor Facility Aware Date05/04/2012
Event Location Hospital
Date Report TO Manufacturer05/04/2012
Date Manufacturer Received05/04/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 05/29/2012 Patient Sequence Number: 1
#TreatmentTreatment Date
NA
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