MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR 4.0MM SUCT LOPROFILE -EA; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Catalog Number	225361
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/26/2017
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: the complaint device was received and evaluated.The device was visually inspected.The active tip shows signs of activation.There are signs of slight melting on the manifold between 3 - 9 o'clock positions of the tip.Functional testing could not be carried out due to device condition.The root cause of this event has been reviewed against the supplier risk analysis and is consistent with the expected outcome of such an event.This complaint can be confirmed.A manufacturer corrective and preventative action (capa) investigation has been initiated to investigate this issue further in an effort to determine root cause and to identify appropriate corrective actions.A device history record (dhr) 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 dissimilar complaints from this lot of devices that were released to distribution.Corrective actions to be identified through manufacturer capa if a root cause is found then appropriate corrective actions will be identified and implemented accordingly; there are none to be implemented at this time.Depuy 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.(b)(4).
Event or Problem Description
It was reported that during the procedure the radio frequency presented a failure in the sterile material; the ceramic melted during the procedure.A new one had to be opened; that one did not fail.

• Brand Name: VAPR 4.0MM SUCT LOPROFILE -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: 7781851
• Report Number: 1221934-2018-53245
• Device Sequence Number: 19154286
• Product Code: GEI
• UDI-Device Identifier: 10886705009381
• UDI-Public: 10886705009381
• Combination Product (Y/N): N
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/26/2017

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: 06/30/2018
• Device Catalogue Number: 225361
• Device Lot Number: U1507194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2017
• Initial Report FDA Received Date: 08/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1