MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR3.5MMFLEXSIDEEFFECT1-PCEELECTRODE-EA; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Model Number	227312
Medical Device Problem Codes	Use of Device Problem (1670); Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).Investigation summary: according to the information provided, it was reported that the vaporizer displays an error message.Error 300, error 400.The device was received for evaluation.Visual inspection revealed that the cable and the connector are in good condition as well as the pins.The tip does not shows signs of activation.The device will be sent to the manufacturer for further evaluation.Manufacturer evaluation result for vapr3.5mmflexsideeffect1-pceelectrode-ea: the device has not been returned in its original packaging.The distal tip of the device shows no signs of use.No visible damage to shaft, cable or plug.The electrical test was performed, as a result, all the parameters passed except the primary capacitance test.Functional testing was conducted using vapr vue generator (gml4854/2); the generator default values, maximum settings available and activation test failed.Manufacturer summary: the customer claimed that the device did not function.The capacitance value of the device was found to be above top specification.When plugged into the generator incorrect higher default settings were displayed.When the device tip was placed into saline, the generator display would change to ¿invalid error¿ message.Removal of the device from the saline would change the display back to the incorrect defaults.The capacitance value was remeasured while the tip was in saline and found to be further outside of specification.The defect seen in consistent with previous complaint devices investigated under supplier corrective action caused by a fault within the overmould of the plug.The failure mode seen results in the generator not recognising the electrode and a delay or cancellation of procedure ¿ patient(s) under anaesthetic as considered in the systems risk assessment.The failed device did not pose any significant risk to patient safety.A review of our complaint records over the last 12 months to assess the frequency of this defect to be low occurrence and is as anticipated in the risk analysis.This issue has been deemed a supplier issue and the investigation has already been completed under supplier corrective action (scr-1754).The complaint device was manufactured prior to these corrective actions.A dhr review has been performed for the complaint device lot number u2004015; no issues (ncrs or deviations) with the manufacturing process have been indicated which might explain the failures observed.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.
Event or Problem Description
It was reported by the sales rep in (b)(6) that during a knee arthroscopy procedure on (b)(6) 2021, it was observed that the vapr flexible side effect electrode w/integrated handpiece, 3.5mm x 160mm device displayed error messages: 300 and 400.During in-house engineering evaluation, it was determined that the device did not coagulate.Another like device was used to complete the procedure.With a delay of 10 minutes.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: VAPR3.5MMFLEXSIDEEFFECT1-PCEELECTRODE-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: 12040073
• Report Number: 1221934-2021-01943
• Device Sequence Number: 19823173
• Product Code: GEI
• UDI-Device Identifier: 10886705009725
• UDI-Public: 10886705009725
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/21/2021

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: 03/31/2023
• Device Model Number: 227312
• Device Catalogue Number: 227312
• Device Lot Number: U2004015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1