MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR 3.5MM FLEX SIDE -EA; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Catalog Number	225312
Medical Device Problem Code	Electromagnetic Interference (1194)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Evaluation statement: this complaint is being closed since after multiple email attempts to retrieve the product and to gather additional information, the product still hasn't been returned for evaluation.No additional information has been received.If and when the device in question is received, this file will be reopened and its contents made to reflect the results of the evaluation.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 2 dis-similar complaints for this lot of devices that were released to distribution.We cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required and 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.This report is being filed from the etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported the electrode caused disturbances in the vio 3- erbe device when used normally.The vio 3- erbe stood on the tower but was not in use.Only the neutral electrode was attached to the patient.During the use of the vapr the vio 3 jumped through its program, indicating a failure by the vapr.Customer had purchased 2 other electrodes with the same batch, which did not work which is captured in complaint 15126mt.The customer has eleven (11) more unopened electrodes from the same batch which will be returned.New electrodes will be purchased.

• Brand Name: VAPR 3.5MM FLEX SIDE -EA
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7885009
• Report Number: 1221934-2018-54669
• Device Sequence Number: 19317635
• Product Code: GEI
• UDI-Device Identifier: 10886705009312
• UDI-Public: 10886705009312
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K974022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 225312
• Device Lot Number: U1506076
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2015
• Initial Report FDA Received Date: 09/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1