MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR P50 W/ HAND CONTROLS; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Model Number 228504

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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).

Event Description

It was reported by affiliate via email that during a knee arthroscopy the coagulation button of the vapr p50 w/ hand controls didn¿t worked, it was also tested with the pedal and it didn¿t coagulate, the console was switched and the failure continued.The procedure was completed using another device.No patient consequence and no surgical delay was reported.No additional information was provided.

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.Subsequent follow-up with the customer, additional information was received.It was reported that there was no delay in the surgery.A manufacturing record evaluation was performed for the finished device lot/serial number (b)(4), and no non-conformances were identified.

Manufacturer Narrative

Product complaint # (b)(4).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.Investigation summary
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> according to the information provided, it was reported that the device did not work on coagulation mode.The complaint device was not returned, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.Since the complaint device was not received, we cannot determine a root cause for the reported failure.If the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device lot number [u1907188], and no non-conformances were identified.At this point in time, no corrective action is required, and 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.Udi: (b)(4).

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 device did not work on coagulation mode.The complaint device was received and evaluated.Visual inspections revealed no anomalies on the tip and presented signs of activation.The electrode was connected to a vapr vue generator and all correct default settings were made available.The generator was set to maximum power and presented intermittent ablation and coagulation modes.The electrode was tested several times to ensure the malfunction.Device was sent to supplier for further evaluation.Supplier evaluation result for vapr p50: the device was received in laboratory for analysis under the (b)(4).The device has not been returned in its original packaging,the active tip of the device is in a used condition and there is tissue visible in the suction hole,the device shaft, cable and plug appear in a good condition.The electrical test was performed with the different parameter (active continuity, return continuity, primary capacitance, secondary capacitance, and hipot active-return), as a result the device passes all parameter.The device was functional testing using vaprvue generator (gml4808/3), the test included different values as a setting and the activation in ablate and coagulation passed.Supplier summary: the investigation could not substantiate the customer¿s claim that the devices presented a coagulation failure.All three devices successfully passed both the electrical and functional tests.When activated the performance of all devices was a expected on both ablate and coag modes.From our investigation we have been unable to confirm the customer reported defect or find any other defect as all three returned electrodes were found to function as expected and meet the manufacturers specification.It may be possible that there was a fault elsewhere in the electrosurgical system however this cannot be confirmed.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.

• Brand Name: VAPR P50 W/ HAND CONTROLS
• 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: 9460753
• MDR Text Key: 208178607
• Report Number: 1221934-2019-59946
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705020942
• UDI-Public: 10886705020942
• Combination Product (y/n): N
• PMA/PMN Number: K122425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 228504
• Device Catalogue Number: 228504
• Device Lot Number: U1907188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2019
• Date Manufacturer Received: 09/11/2020
• Patient Sequence Number: 1