MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR TEMPERATURE CONTROL END EFFECT ELECTRODE W/INTEGRATED HANDPIECE; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Catalog Number	227252
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary = > the complaint device is not being returned; it was discarded by the customer and therefore is unavailable for a physical evaluation.A device history 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 evidence of manufacturing anomalies on the paperwork reviewed.Further, a review into the depuy synthes mitek complaints system revealed two other similar complaint 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.(b)(4).
Event or Problem Description
It was reported via email from the sales rep that during a knee procedure, small bits of black plastic coating was coming off of the vapr temperature control end effect electrode tip while inside the patient.The fragments were removed.There was an eight minute delay with no patient consequences.The device is not being returned for evaluation.

• Brand Name: VAPR TEMPERATURE CONTROL END EFFECT ELECTRODE W/INTEGRATED HANDPIECE
• 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: 7578644
• Report Number: 1221934-2018-51462
• Device Sequence Number: 14122802
• Product Code: GEI
• UDI-Device Identifier: 10886705009664
• UDI-Public: 10886705009664
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082643
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2018

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: 04/30/2020
• Device Catalogue Number: 227252
• Device Lot Number: U1705080
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2018
• Initial Report FDA Received Date: 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1