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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK MITEK VAPR COOL PULSE 90 ELECTRODE, W/O HAND CONTROLS; ELECTROSURGICAL: CUTTING AND COAGULATING
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DEPUY MITEK MITEK VAPR COOL PULSE 90 ELECTRODE, W/O HAND CONTROLS; ELECTROSURGICAL: CUTTING AND COAGULATING Back to Search Results
Catalog Number 228146
Device Problem Unknown (for use when the device problem is not known) (2204)
Patient Problem Unknown (for use when the patient's condition is not known) (2202)
Event Date 06/16/2015
Event Type  Injury  
Event Description
The surgeon was using the device and notice that steam was coming out from the patient.Surgeon immediately stop and open a same like product to proceed with the procedure.Product specialist was present during the procedure.No delay in surgery.No adverse event to patient.
 
Manufacturer Narrative
Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy synthes mitek however it is not known if it will be received within the 30 day reporting requirement, therefore depuy synthes mitek would like to file this initial medwatch report at this time.When and if additional information is received it will be reflected in a follow-up medwatch report.In transit.
 
Manufacturer Narrative
Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy synthes mitek however it is not known if it will be received within the 30 day reporting requirement, therefore depuy synthes mitek would like to file this initial medwatch report at this time.When and if additional information is received it will be reflected in a follow-up medwatch report.
 
Event Description
The surgeon was using the device and notice that steam was coming out from the patient.Surgeon immediately stop and open a same like product to proceed with the procedure.Product specialist was present during the procedure.No delay in surgery.No adverse event to patient.
 
Manufacturer Narrative
The complaint device was received and evaluated.Visual observation under magnification revealed no anomalies on the active tip.There was saline residue in the suction tube indicating the device had been used.The electrode was connected to a vapr vue generator and all correct default settings were made available.The generator was set to maximum power for ablation and coagulation modes and activated in saline successfully indicating that the device was fit for function at the time of use.The electrode was tested several times to ensure continuity of function.The reported failure cannot be confirmed and we cannot determine what caused the user to experience reported problem.A batch record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy synthes mitek complaints system revealed one other dissimilar complaint for this lot of devices that were released to distribution.At this point, no further action is warranted.However, depuy synthes 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.
 
Event Description
The surgeon was using the device and notice that steam was coming out from the patient.Surgeon immediately stop and open a same like product to proceed with the procedure.Product specialist was present during the procedure.No delay in surgery.No adverse event to patient.
 
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Brand Name
MITEK VAPR COOL PULSE 90 ELECTRODE, W/O HAND CONTROLS
Type of Device
ELECTROSURGICAL: CUTTING AND COAGULATING
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
bahaa nashed
325 paramount drive
quality department
raynham, MA 02767
8003824682
MDR Report Key4917074
MDR Text Key17933461
Report Number1221934-2015-00869
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K113545
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative,Distributor
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 06/16/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/31/2017
Device Catalogue Number228146
Device Lot NumberU1501165
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/17/2015
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date06/16/2015
Device Age3 MO
Event Location Hospital
Date Report to Manufacturer06/16/2015
Date Manufacturer Received06/16/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/05/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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