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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK MITEK VAPR S90 ELECTRODE 4.0MM SUCTION W/INTEGRATED HANDPIECE; ELECTROSURGICAL: CUTTING AND COAGULATING
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DEPUY MITEK MITEK VAPR S90 ELECTRODE 4.0MM SUCTION W/INTEGRATED HANDPIECE; ELECTROSURGICAL: CUTTING AND COAGULATING Back to Search Results
Catalog Number 225370
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 04/28/2015
Event Type  malfunction  
Event Description
The electrode was being used when the electrode started to spark within the patient's shoulder.The chief surgery nurse reported that the vapr system [loaner] gave the error message, "shorted out." the surgeon requested another electrode which was used to continue the surgery without any further incident.The chief surgery nurse reported that there was no indication of problems with the electrode prior to surgery.
 
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 (b)(4), 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.
 
Manufacturer Narrative
The complaint device was received and forwarded to the supplier for evaluation.Visual observation of the electrode reveals the distal tip shows signs of activation.There is tissue debris around the tip and saline solution stains on device surface and in the suction tube.Under magnification, it was observed that the manifold shows small signs of melting at 7 o'clock position of the tip.This damage to the tip would lead to the sparking at the active tip, confirming this complaint.The ifu states: ¿observe extreme caution when using electro surgery in close proximity to or in direct contact with any metal objects.The majority of arthroscopes and arthroscopic instruments are metal.Do not activate the electrode while any portion of the electrode and the adjacent metal object may result in product damage.¿ no further information was provided to determine if the above mentioned factors contributed to this failure.Due to an increasing trend in the number of this reported failure, a supplier corrective action has been initiated.Root cause: the design is such that the operator requires a specific aptitude to ensure the glue wicks successfully; this aptitude is not presently ensured by the training program or by the electrode design.Corrective action: awareness retraining, clip application video retraining has been provided to the operators.This capa is currently being monitored for its effectiveness.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.Since the function of the electrode is to ablate tissue, the risk associated with sparking of the electrode tip within the joint space is low.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 electrode was being used when the electrode started to spark within the patient's shoulder.The chief surgery nurse reported that the vapr system [loaner] gave the error message, "shorted out".The surgeon requested another electrode which was used to continue the surgery without any further incident.The chief surgery nurse reported that there was no indication of problems with the electrode prior to surgery.
 
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 electrode was being used when the electrode started to spark within the patient's shoulder.The chief surgery nurse reported that the vapr system [loaner] gave the error message, "shorted out." the surgeon requested another electrode which was used to continue the surgery without any further incident.The chief surgery nurse reported that there was no indication of problems with the electrode prior to surgery.
 
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Brand Name
MITEK VAPR S90 ELECTRODE 4.0MM SUCTION W/INTEGRATED HANDPIECE
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 Key4848216
MDR Text Key5869593
Report Number1221934-2015-00830
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K122425
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative,Distributor
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 05/19/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number225370
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/25/2015
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date05/19/2015
Event Location Hospital
Date Report to Manufacturer05/19/2015
Date Manufacturer Received05/19/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Patient Sequence Number1
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