MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR VUE WIRELESS FOOTSWITCH; FOOT-SWITCH, ELECTRICAL

Model Number 227214

Device Problem Blocked Connection (2888)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2021

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).Investigation summary: the complaint device was received at the service center and evaluated.It was reported that wireless pedal will not pair.Per service reports, this complaint can be confirmed.During the service evaluation the following defects were identified: footswitch : pairing failure- due to bad battery tray assembly.There are broken inserts on the housing of the unit, and repair would require replacement of the housing.Minor scratches on the unit.Since the housing cannot be replaced, this unit is deemed unrepairable.No further testing or repairs on the unit will be conducted, and the unit will be placed into long term hold.The faulty parts was identified as the root cause for the device failure during the service evaluation.Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.At this point in time, no corrective action is required, and no further action is warranted.Depuy 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.

Event Description

It was reported by the sales rep that preoperatively to an unknown surgery on (b)(6) 2021, it was observed that the vapr vue wireless footswitch device would not pair.During in-house engineering evaluation, it was determined that the device had broken inserts on the housing.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• Brand Name: VAPR VUE WIRELESS FOOTSWITCH
• Type of Device: FOOT-SWITCH, ELECTRICAL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12923918
• MDR Text Key: 281674660
• Report Number: 1221934-2021-03578
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705009657
• UDI-Public: 10886705009657
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 227214
• Device Catalogue Number: 227214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Date Manufacturer Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1