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

Model Number 227312

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Udi: (b)(4).Initial reporter facility name: (b)(6).A manufacturing record evaluation was performed for the finished device lot/serial number u1810165, and no non-conformances were identified.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported by the affiliate in (b)(6) that during an excision of bursa, it was observed that the vapr flexible side effect electrode w/integrated handpiece, 3.5 mm x 160 mm device, was not able to ablate nor coagulate.It was reported that there was no alert code showed on the screen.The procedure was completed with a replacement of the device.No surgical delay or patient consequence reported.There was no delay in the surgical procedure.There was a spare device available for use to complete the surgery.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

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.H10 additional narrative: investigation summary
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> according to the information provided, it was reported that during the surgery of excision of bursa, it connected with generator, did not work (could not cut and could not coagulate), no any alert code showed in the screen.The device was received, and visual inspection was performed.It was not identified signs of activation, shaft, cable and plug appear in good conditions, however; the shaft was observed with some degree of misalignment.The device was sent to the manufacturer for further investigation.Supplier evaluation result for one piece vaprflex side effect electrode: the device has not been returned in its original packaging.The active tip of the device does not show any obvious signs of activation, the device shaft, cable and plug appear in a good condition.Although the shaft of the electrode does show some degree of misalignment on receipt.However, the design the shaft of these electrodes are designed to be flexible.The electrical test was performed with the different parameter (active continuity, return continuity, primary capacitance, primary capacitance, and hipot active return), as a result the device only failed in the case of primary capacitance.The device was functional testing using a vapr vue generator gml4854/2, the test included different values as a setting of the activation in ablate and coagulation, the results confirm that the tests failed since a message error (invalid instrument) was displayed in the generator.Therefore, the device could not be activated in either cut or coagulation modes.The device was not recognized by the generator by the capacitance of the electrode being significantly out of specification.During the investigation, the capacitance was measured to be 3.25nf, resulting in the generator not recognizing the device and displaying the ¿invalid instrument¿ error message.The stamp i.D on the plug of the electrode states the capacitance required.The possible route cause can be attribute to the device requirements.Since the capacitor and electrical connections are over molded into the plug, no further deconstruction could be conducted.It is therefore likely that either: the capacitor has been damaged within the plug, or the wrong capacitor has been used.Supplier summary: the initial customer of the device ¿not working¿ can be confirmed.The capacitance value of the returned device was significantly out of specification, resulting in the device not being recognized by the generator.No further deconstruction of the device was possible and can only be assumed that the incorrect capacitance was either caused by the incorrect or damaged capacitor.From our investigation we were able to confirm an intermittent recognition fault with the electrode and have determined the likely cause of the failure to be defective capacitor inside the plug assembly.The defect seen is likely to have been intermittent therefore passing end of line testing.A continuous review of complaints will be performed and if any adverse trend is noted a further review of this decision will be undertaken.A manufacturing record evaluation was performed for the finished device lot/serial number (b)(6), and no non-conformances were identified.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.Device history review
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> a manufacturing record evaluation was performed for the finished device lot/serial number (b)(6), and no non-conformances were identified.

• Brand Name: VAPR3.5MMFLEXSIDEEFFECT1-PCEELECTRODE-EA
• Type of Device: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9489589
• MDR Text Key: 204716862
• Report Number: 1221934-2019-60036
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705009725
• UDI-Public: 10886705009725
• Combination Product (y/n): N
• PMA/PMN Number: K082643
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 227312
• Device Catalogue Number: 227312
• Device Lot Number: U1810165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Date Manufacturer Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1