MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR3.5MMSDEEFFECT21DEG1-PC ELECTRODE-EA; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Model Number	227302
Medical Device Problem Code	Blocked Connection (2888)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).The lot number is unknown.
Event or Problem Description
It was reported by the affiliate by customer's mail that during an unknown procedure the vapr generator was turned on and started appropriately but when the vapr3.5mmsdeeffect21deg1-pc electrode-ea was plugged in it was not recognize by the vapr generator.The procedure was completed using another electrode.No patient consequence and no surgical delay was reported.No additional information was provided.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.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
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional information: d4, h4: the lot number, expiration date, and device manufacture date were all reported as unknown on the initial report.All fields have been updated accordingly to reflect the correct information.Udi: (b)(4).
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 electrode (angled side effect electrode) was plugged in but not recognized by the vapr generator.The complaint device was received and evaluated.Device was visual inspected and there was no anomalies noted.Upon testing, showing invalid instrument error.Therefore, the device was sent to supplier for further evaluation.Supplier evaluation result for vapr premiere vapr3.5mmsdeeffect21 electrode-ea: the device has not been returned in its original packaging.The distal end of the device is in an unused condition.Also, the plug has no lanterns fitted to the plug pins.The electrical test was performed with different parameter; as a result, the capacitance test failed.Supplier summary: the customers claim of the electrode ¿not recognized by the vapr generator¿ could be substantiated.The testing discovered that initial connection of the device did not present the expected default settings on the generator display.When the device was attempted to be activated in saline the display changed to ¿invalid instrument¿.Therefore, the plug and cable assembly was sent for x-ray.This confirmed that the twisted connection between capacitors are in close proximity to the active pin if not touching.A supplier corrective action (scr-148) was raised and it was closed after implementing corrective and preventative actions.The plug and cable assemblies (279002) for the recent complaints has the same batch number car1013578, which was post supplier corrective action.As a result of this, a new supplier corrective action has been raised (scr-1754), as the id capacitance test within the generator did not detect the assembly.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".A manufacturing record evaluation was performed for the finished device [u1906071] number, and no non-conformances were identified.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.

• Brand Name: VAPR3.5MMSDEEFFECT21DEG1-PC 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: 9661144
• Report Number: 1221934-2020-00438
• Device Sequence Number: 3675270
• Product Code: GEI
• UDI-Device Identifier: 10886705009688
• UDI-Public: 10886705009688
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K082643
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/22/2020

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: 05/31/2022
• Device Model Number: 227302
• Device Catalogue Number: 227302
• Device Lot Number: U1906071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Initial Date Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 02/12/2020; 02/13/2020; 10/14/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 02/13/2020; 02/14/2020; 10/15/2020
• Patient Sequence Number: 1