MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR3 FOOTSWITCH *EA; FOOT-SWITCH, ELECTRICAL

Catalog Number 225023

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Device was used for treatment, not diagnosis.Udi: (b)(4).The lot number is unknown.

Event Description

It was reported by the sales rep via phone that during a rotator cuff repair procedure the coag pedal on the customer's vapr 3 foot pedal would not work.The procedure was completed with another pedal with no patient harm or surgical delay to the case.The sales rep could not provide a lot number for the device as it was not readable.The device will be returning for evaluation.

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.H3, h6: the device was received for evaluation.Visual inspection reveals that the fischer cap is missing from the connector.The device appears to be very old.There is corrosion around the pedals on the housing.The dome is missing from the mode button.The device was taken to a lab and tested.It was connected to a vapr vue generator with an electrode attached.The ablate and coag pedals were tested and functioned as intended.This testing procedure was repeated several times to confirm the continuity of function.The mode button was not tested because of the missing dome.This complaint cannot be confirmed for the reported failure.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.Therefore, we cannot determine what caused the user to experience the reported event, we cannot discern a root cause for the reported failure mode.Furthermore, the lot number on the bottom of the device was not legible which precludes conducting a manufacturing record evaluation review.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.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.

• Type of Device: FOOT-SWITCH, ELECTRICAL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9146917
• MDR Text Key: 205365822
• Report Number: 1221934-2019-58777
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705009114
• UDI-Public: 10886705009114
• Combination Product (y/n): N
• PMA/PMN Number: K041135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 225023
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Date Manufacturer Received: 11/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1