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

Catalog Number 227214

Device Problems Break (1069); Blocked Connection (2888)

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

Event Date 12/10/2021

Event Type  malfunction  

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 there were broken inserts on the housing of the device.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

Manufacturer Narrative

Udi: (b)(4).Investigation summary: the complaint device was received at the service center and evaluated.It was reported that the fms wireless pedal will not pair.Per service reports, this complaint can be confirmed.During the service evaluation the following defects were identified: minor scratches on the unit; low batteries; broken inserts on the housing of the unit; footswitch: pairing failure.Since the housing cannot be replaced this unit is deemed unrepairable.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.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.Device history lot: 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.

• 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: 13359679
• MDR Text Key: 289961179
• Report Number: 1221934-2022-00300
• Device Sequence Number: 1
• Product Code: GEI
• 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

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 Catalogue Number: 227214
• Device Lot Number: 1110035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Initial Date Manufacturer Received: 01/19/2022
• Initial Date FDA Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2011
• 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