MAUDE Adverse Event Report: DEPUY MITEK VAPR III LOW PROFILE SUCTION ELECTRODE; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Catalog Number	225361
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2014
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.The complaint device was received and forwarded to the supplier for investigation.Visual observation of the active tip indicates signs of activation and the manifold at 8 o'clock position of the tip shows signs of melting.This damage to the active tip would lead to the reported failure, confirming this complaint.Moreover, upon close inspection, it was found out that the o-ring, at the proximal end of the device, is missing.The primary purpose of this 0-ring is to provide a seal within connector handpiece, ensuring the electrical connections between the handpiece and the electrode remain saline free.A secondary purpose would also ensure a tight fit within the handpiece.A batch record review has been conducted and the 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 mitek complaints system revealed one dissimilar complaint for this lot of devices that were released to distribution.(b)(4).This report is being filed from the (b)(4) 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 by the affiliate in (b)(6) that the output-error alarm continued during rotator cuff repair surgical procedure.The surgeon pushed the footswitch with the device outside the patient¿s body to check the functionality and the device sparked at the lateral side.The device was replaced by the side effect electrode with the same handpiece and the procedure was completed without further issue.The device in question was used with vapr3 with the output levels at cutting 180/coagulation 120.There was no surgical delay or harm to the patient because of this problem.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: VAPR III LOW PROFILE SUCTION ELECTRODE
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7717996
• Report Number: 1221934-2018-52441
• Device Sequence Number: 1065236
• Product Code: GEI
• UDI-Device Identifier: 10886705009381
• UDI-Public: 10886705009381
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113545
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/14/2014

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: 08/31/2016
• Device Catalogue Number: 225361
• Device Lot Number: U1309137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2014
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2014
• Initial Report FDA Received Date: 07/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1