MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR COOLPULSE90 ELECTRODE; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Model Number 228146

Device Problem Suction Failure (4039)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2019

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).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 unspecified surgical procedure, it was observed that the suction on the vapr coolpulse90 electrode device did not work.The surgery was completed with new electrode without any delay nor harm to the patient.There was anodelay 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.The exact date of the event was unknown but was noted to have occurred in 2019.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: additional information: investigation summary: according to the information provided, it was reported that vapr coolpulse90 electrode was not able to suction device was sent to supplier for further evaluation.Supplier evaluation result for vapr coolpulse90 electrode: the device has not been returned in its original packaging.The active tip looks in a used condition, with evidence of activation on and around active tip, the suction tube of the device show evidence of use, with evidence of dried saline within.However, the suction tube appears free from any blockage.No visible damage to the device shaft,handle, cable or plug.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, the flow rate test was failed.The initial customer complaint of ¿suction did not work¿ can be confirmed.Several attempts were made to unblock the device, by activating the device in saline, whilst applying a positive and negative pressure to the suction tube.The device handle was opened and inspected for any anomalies or blockages within the visible suction path.The suction tube/shaft connection within the handle did show some degree of visual debris.This was cleaned by inserting a thin gauge wire up through the suction tube (proximal end).This resulted in no clear blockage and was only discolouration of the tube.The thin gauge wire was also inserted through the suction port of the device at the active tip, and gently pushed until resistance.Some ¿blockage was encountered approximately 30mm from the suction tube/tube connector within the handle.By manipulating the wire gently, the blockage was removed and the thin gauge (inserted into the suction path at the active tip) wire was inserted until it was visible through the clear suction tube.The flow rate of the device was measured again, and measured to be 159.91ml/min.Although a vast improvement, still outside that of the device specification.The above process was repeated several times, and further debris was cleared from the suction path.There have been instances whereby these devices have become blocked due to uv glue within the suction path, but from the evidence this is not the case in this instance.The flow rate was re-measured and found to be 180.1ml/min; within the device specification.Supplier summary: the initial customer complaint stating that ¿suction did not work¿ can be confirmed.The device was electrically sound, and activated as intended.The initial suction flow was measured to be zero flow.A blockage was identified within the suction tube of the device and after several attempts made to clear the blockage, a final flow rate of 190.1ml/min was measured, within the device specification.The device was confirmed to be blocked caused by tissue within the suction path of the device.With the tissue debris removed, the device exhibited a flow rate within device specification.From our investigation we were able to confirm the customer reported blocked suction issues with the returned electrode however no manufacturing defect was found and we have determined the root cause of the reported suction blockage to be normal procedural debris within the active tip which was removed during testing of the device.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 lot: a manufacturing record evaluation was performed for the finished device lot/serial number (b)(6), and no non-conformances were identified.

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: correction: b3; the date of event was inadvertently missed on the initial report and has been updated to reflect the correct information.Additional information: 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.A manufacturing record evaluation was performed for the finished device lot/serial number (b)(6), and no non-conformances were identified.

• Brand Name: VAPR COOLPULSE90 ELECTRODE
• 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: 9364443
• MDR Text Key: 208325594
• Report Number: 1221934-2019-59725
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705010080
• UDI-Public: 10886705010080
• Combination Product (y/n): N
• PMA/PMN Number: K113545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 228146
• Device Catalogue Number: 228146
• Device Lot Number: U1903131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Date Manufacturer Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1