MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR3.5MM SIDEEFFECT 1-PCE ELECTRODE-EA; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Model Number	227301
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2020
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.Udi: (b)(4).Investigation summary: according to the information provided, it was reported that during arthroscopy there was an alert message on the generator with vapr2.3mm side shrt 1-pce electrode -ea and vapr3.5mm sideeffect 1-pce electrode-ea.3.The complaint device was received and evaluated.Device was visual inspected and there was no anomalies noted.Upon testing, the electrode presented intermittent operation during ablation and coagulate; and after a time, showed invalid instrument error.Therefore, the device was sent to supplier for further evaluation.Supplier evaluation result for vapr3.5mm sideeffect 1-pce electrode-ea: the device has not been returned in the original packaging.The distal tip shows signs of use, with tissue debris being visible around tip.The ceramic at the distal tip is marked again showing signs of use.The cable and plug of the device show no obvious signs of damage.The electrical test was performed; as a result, the active continuity was failed.Functional testing was conducted using vaprvue generator (gml3735/3); the following result showed that during ablate and coagulate did not present any activation.When attempting to activate the device in saline the message of invalid instrument would appear on the display.Placing the device in and out of saline changes the display settings from the recorded values to invalid instrument.After the above testing the device remained on invalid instrument and could not be changed.Supplier summary: the customer claim of the generator showing an alert message when plugged into a generator was confirmed.As described above, more errors were noted as the device was evaluated.Instances of invalid instrument, output short and incorrect default settings were displayed on the generator, depending on whether the distal tip of the device is in or out of saline.The complaint device was manufactured prior to these corrective actions.This fault has previously been seen and was caused by the twisted connection between capacitors being in close proximity to the active pin within the overmould of the plug.The capacitors ideally should be situated away from the pins to ensure there are no capacitance issues from components touching.This issue has been deemed a supplier issue and the investigation has already been completed under supplier corrective action (scr-1754).The failure symptom of capacitor position abnormal was analyzed during manufacturing process; as a result, there were some points to need to improve: impact to the cable risks, injection machine, the importance of self-inspection, the localization of the cable during injection.Therefore, the corrective and preventive actions were created, see attachment "scr-1754".A dhr review has been performed for the complaint device lot number u1912021; no issues (ncrs or deviations) with the manufacturing process have been indicated which might explain the failures observed.Based on a review of the product ra no containment or correction action related to the individual complaint is required.At this point in time, 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
It was reported by the affiliate in (b)(6) that preoperatively to an arthroscopy procedure on (b)(6) 2020, it was observed that an electrode device prompted an unspecified alert message on the generator.During in-house engineering evaluation, it was determined that there were tissue debris being visible around the tip on the electrode device.Another like device was used to complete the procedure with a three minute delay.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: VAPR3.5MM SIDEEFFECT 1-PCE ELECTRODE-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: 11154320
• Report Number: 1221934-2021-00095
• Device Sequence Number: 4132473
• Product Code: GEI
• UDI-Device Identifier: 10886705009671
• UDI-Public: 10886705009671
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K082643
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/11/2021

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: 11/30/2022
• Device Model Number: 227301
• Device Catalogue Number: 227301
• Device Lot Number: U1912021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 01/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1