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

Catalog Number 225028

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Not Applicable (3189)

Event Date 01/01/2019

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 shoulder arthroscopy surgical procedure, it was observed that the electrode went on without touching while the vapr was outside the patient.The generator stated: ¿cut/coag stuck¿.It was then tested but afterwards, the electrode reacted strange on the buttons.There was a delay of ten minutes as they had to tried to solve the problem and open a new one.The surgery was completed using another electrode.There was a 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.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.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 : the device was received and evaluated.The reported condition will not coag can be confirmed and error code 600 cannot be confirmed.Confirmed.It was observed that the active tip of the device appeared activated and saline residue was present in the suction tubing indicating that the device had been previously used.No anomalies on tip, cord or handle.The device was connected to a test generator to test the functionality of the device.The device was activated in both ablate and coagulate modes for several seconds,it was observed that 2 of 3 coag buttons don't work.1 ablate button doesn't work.The device was forwarded to the manufacturer for further investigation into the observed failures.The manufacturer indicated that there were faults with three buttons that resulted in continuity failures.Activation tests found that two of the buttons (ablate sw4 & coag sw1) would intermittently work, whereas the remaining coag button (sw5) did not operate during any of the tests.The customer observation of the device working without touching it could not be replicated.Inspection of the buttons observed some white and green staining but further investigation will be required to assess if this is a factor in the faults.The likely cause of the defect to be a supplier manufacturing defect relating to the switch pcb assembly.The evidence observed is consistent with previous devices that have been investigated under capa investigation which has identified the components used in the process are not compatible for this method of joining.A manufacturing record evaluation was performed for the finished device lot/serial number (b)(4) , 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)(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.Udi: (b)(4).

• 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: 9342739
• MDR Text Key: 208347006
• Report Number: 1221934-2019-59592
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 10/23/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 225028
• Device Lot Number: U1906160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Initial Date Manufacturer Received: 10/23/2019
• Initial Date FDA Received: 11/19/2019
• Supplement Dates Manufacturer Received: 11/20/2019; 12/24/2019
• Supplement Dates FDA Received: 12/16/2019; 12/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1