MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR 3.5MM SIDE 21 DEG -EA; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Model Number	225302
Medical Device Problem Code	Residue After Decontamination (2325)
Health Effect - Clinical Codes	No Patient Involvement (2645); Not Applicable (3189)
Date of Event	12/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: according to the information provided, it was reported that an unknown procedure performed on dec.4, 2019.Although the surgeon raised output level to the maximum of the electrode (225302).Ablation feature did not work.The complaint device was received and evaluated.The electrode was not presented physical damages, were tested and both modes were pass.The electrodes will be send to gyrus for further investigations.Supplier evaluation result for vapr 3.5mm side 21 deg -ea: the device was not returned in the original packaging, no handpiece returned, device shows evidence of activation, with tissue debris being visible at tip, devices show evidence to a handpiece.The electrical test was performed with the different parameters (capacitance, continuity active, continuity return, and hipot) as a result all pass.During functional test, the activation test ablation and coagulation mode were fail.The device was functional testing using vaprvue generator (gml3723/4), the test included different values as a setting and the activation in ablate and coagulation pass.Supplier summary: the customer claim of the ablate function not working could not be substantiated.Both returned devices functioned as expected.It should be noted that no handpiece was returned, therefore one from pe stock was utilised to complete the testing.From out investigation we were unable confirm the reported fault or find an other fault with the complaint device, the customers electrode was found to function as expected and meet the manufacturers specification.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.At this point, 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.
Event or Problem Description
This is report 1 of 2 for the same event.It was reported by the affiliate in (b)(6) that during an unknown procedure, it was observed that the ablation feature on the electrode device did not work.The procedure was completed less than 30-minute surgical delay.There was no harm to the patient.The device was the first use when the issue occurred.During in-house engineering evaluation, it was determined that the device showed evidence of activation with tissue debris being visible at tip.There were no patient consequences reported.No additional information could be provided.

• Brand Name: VAPR 3.5MM SIDE 21 DEG -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: 10489883
• Report Number: 1221934-2020-02390
• Device Sequence Number: 4060469
• Product Code: GEI
• UDI-Device Identifier: 10886705009268
• UDI-Public: 10886705009268
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Type of Report: Initial
• Report Date (Section B): 08/31/2020

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: 03/31/2024
• Device Model Number: 225302
• Device Catalogue Number: 225302
• Device Lot Number: U1904074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1