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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEKMITEK VAPR COOL PULSE ELECTRODEELECTROSURGICAL: 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  
Manufacturer Narrative

The complaint device was received and evaluated visually: both with the naked eye and under power. Noted: the shaft only was received; it has been purposefully cut away from its handle, which precludes conducting any physical testing. The complaint narrative states that something at the distal end of the device broke away into the body, however, we cannot discern any damage (outside of the facility's intentional severance) to the device. The sample was thoroughly examined by several individuals, and they could not see any damage or anomalies to any part of the sample. The architecture and configuration are totally intact and without any anomaly. We do not know what the users experience was, but it was not with this device. The complaint is not confirmed, the device is without fault. No further action is warranted.

 
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 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.

 
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Brand NameMITEK VAPR COOL PULSE ELECTRODE
Type of DeviceELECTROSURGICAL: CUTTING AND COAGULATION
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 Key2143202
MDR Report Key2115418
Event Key2012394
Report Number1221934-2011-00230
Device Sequence Number1
Product CodeGEI
Report Source Manufacturer
Source Type User facility,Health Professional
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 05/31/2011
1 Device Was Involved in the Event
1 Patient Was 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
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 06/07/2011 Patient Sequence Number: 1
#TreatmentTreatment Date
NA
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