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

Model Number 227214

Device Problems Use of Device Problem (1670); Blocked Connection (2888)

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

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).Investigation summary: the device was received and evaluated at the service center.The reported complaint that the wireless pedal has physical damage and will not pair, was confirmed.It was found that the battery tray assembly had a broken cover and that the base plate screws were missing.The damaged battery tray assembly was replaced along with the missing screws and the device was tested and found to be working according to specifications.User mishandling or a probable fall is most likely the root cause of the physical damage to the device and the missing screws.The defective battery tray assembly has caused the foot switch to not pair as identified during evaluation.There are no indications from this complaint investigation that the failures are manufacturing-related, therefore a manufacturing record evaluation is not required.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: there are no indications from this complaint investigation that the failures are manufacturing-related, therefore a manufacturing record evaluation is not required.

Event Description

It was reported from the sales rep that the vapr vue wireless footswitch devices would not pair.During an in-house engineering evaluation, it was determined that the device had broken in two pieces.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in the procedure or whether a like device was available for use.There were no adverse patient consequences 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: 11496534
• MDR Text Key: 245420005
• Report Number: 1221934-2021-00861
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• 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: 03/09/2021
• Date Manufacturer Received: 03/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1