MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR TRIPOLAR 90 SUCTION ELECT; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Model Number 225028

Device Problem Suction Failure (4039)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Initial reporter phone number: (b)(6).Udi: (b)(4).

Event Description

It was reported by the healthcare professional via email that during an unknown procedure the vapr tripolar 90 suction electrode was not aspirating.Another device was used to complete the procedure.No patient consequences or surgical delay reported.The device is available to be returned for evaluation.

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.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.

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: investigation summary
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> according to the information provided, it was reported that during the procedure, the device was not working.It didn't aspirate.No visual damages in the device, saline residues were observed in the suction tube, sings of activation can be observed.Due to the failure reported is related to suction, the device will be sent to supplier for further evaluation.Supplier evaluation result for vapr tripolar 90 suction elect: device was not returned in the original packaging, the active tip of device shows signs of activation with tissue debris around the periphery, the distal end of the suction appears clear of debris, flow control value received in the open position, the suction tubes show signs of residue, no visible damage on shaft, handle and cable.The electrical test was performed with the different parameters (active continuity, cut return continuity, return continuity, primary capacitance, second capacitance, hipot active-return, hipot active- cut return, hipot return- cut return) as a result the cut return continuity fail and all remaining test were pass.The functional test was performed using the vapr vue generator gml4854/2, including different values as generator connection display, generator default values, minimum settings available, maximum settings available, available waveforms, flow rate and activation test, as result the activation test fail on ablation mode and the remaining test were pass.Summary: the break in cut return continuity was further investigated to establish the root cause.Continuity measurement located the issue to be the connection between the cut return wire to the cable wiring.Continuity measurements recorded the following: plug pin to connector = 0.39o pass, return cap to proximal end of return cap wire = 0.24o pass and proximal end of return cap wire to connector = 42ko fail.We were not able to confirm the report suction issues reported by the customer however we were able to confirm a fault with the device.The complaint device was found to fail both electrical and functional testing.The cause of the defect appears to be related to a missed operation during the manufacturing process.A capa investigation for this failure mode has already been initiated to provide root cause analysis and identify a corrective and/or preventive action plan.This is the 2nd occurrence over the last twelve months.A dhr review has been performed; no issues (ncrs or deviations) with the manufacturing process have been indicated which might explain the failures observed therefore no containment or correction action related to the individual complaint is required.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.

• Brand Name: VAPR TRIPOLAR 90 SUCTION ELECT
• 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: 10814091
• MDR Text Key: 215992369
• Report Number: 1221934-2020-03385
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705023103
• UDI-Public: 10886705023103
• Combination Product (y/n): N
• PMA/PMN Number: K143475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 225028
• Device Catalogue Number: 225028
• Device Lot Number: U2005010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Date Manufacturer Received: 01/02/2021
• Patient Sequence Number: 1