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	Blocked Connection (2888)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Udi: (b)(4).
Event or Problem Description
It was reported that this was an unknown procedure performed on (b)(6) 2020.Preoperatively the handpiece was connected to the main unit which showed ¿insert electrode.¿ the handpiece was replugged in several times, which did not correct the issue.The procedure was completed with a replacement without surgical delay.There was no surgical delay and no harm to the patient.The device was the first use when the issue occurred.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: d10, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary according to the information provided, it was reported that the handpiece was connected to the main unit which showed ¿insert electrode.¿ the handpiece was replugged in several times, which did not correct the issue.The device was received and evaluated.Visual inspection revealed that the electrode is in normal condition, any anomalies on the device could be observed.The contact terminals are in good condition.The tip was found to be in good condition , no signs of activation.Since the electrode arrived without its connector and cable, the functional test could not be performed.The electrode was sent to the manufacturer for further evaluation and testing.Supplier evaluation result for vapr 3.5mm side 21 deg -ea: the device was not returned in the original packaging.No handpiece returned.No evidence of activation at the tip.Evidence that device connected to handpiece.The electrical test was performed; as a result, the continuity test was passed, however, the capacitance test failed.Functional testing was conducted using vapr vue generator (gml4854/2); and available settings were checked and passed.Supplier summary: the customers claim of the device not being recognized when connected to a handpiece could not be replicated.The device was connected to a handpiece and the device functioned as expected, even though the capacitance value was found to be above top specification.It should be noted that no handpiece was returned, therefore one from pe stock was utilized to complete the testing.From our investigation we were unable to confirm the customer reported fault.The returned device was found to function as expected passing both functional and electrical testing with the exception of a high capacitance value.There are two possible causes either a defective capacitor or a connection problem.Although the electrode was recognized on a generator during testing at oste-~uk, generators have tolerance bands so could act differently.Based on the evidence of the customer report and the out of specification capacitor seen during the investigation it is likely the defective capacitor is the root cause of the customers problem.A manufacturing record evaluation was performed for the finished device [u1911053] number, and no non-conformances were identified.At this time, no corrective action is required, and no further action is warranted, as the device is fully functional.However, depuy synthes mitek will continue to track any related complaints within this device family to monitor the extent to which this complaint is observed in the field.

• 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: 10557542
• Report Number: 1221934-2020-02680
• Device Sequence Number: 3538467
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/03/2020

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: 10/31/2024
• Device Model Number: 225302
• Device Catalogue Number: 225302
• Device Lot Number: U1911053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 09/23/2020; 11/20/2020
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 09/24/2020; 11/23/2020
• Patient Sequence Number: 1