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

Model Number 227214

Device Problem Loss of Power (1475)

Patient Problem Not Applicable (3189)

Event Date 12/17/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

As reported by the sales rep phone that the two vapr vue wireless footswitches were being used and found that each had an issue holding the battery charge.They replaced batteries and again the battery drained.They completed the case using a wired pedal which caused a two minute surgical delay in the case to swap out.No patient consequence.

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.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.H10 additional narrative: d4: the serial number was documented as unknown on the initial report and has been updated as (b)(6).Investigation summary: the complaint device was received at the service center and evaluated.The sales rep reported an issue of holding the battery charge and draining.Per service manual operational and diagnostic, this complaint can be confirmed.During evaluation, an internal failure was identified.The issues were resolved with spare parts.A hardware upgrade was also performed.After repair, the device was found to be working according to the specifications.With the available information, we cannot determine the root cause of the reported problem.A manufacturing record evaluation was performed for the finished device lot number [1204126], and no non-conformances were identified.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 history lot: a manufacturing record evaluation was performed for the finished device lot number [1204126], and no non-conformances were identified.

• 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
• MDR Report Key: 9535226
• MDR Text Key: 202758925
• Report Number: 1221934-2019-60213
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705009657
• UDI-Public: 10886705009657
• Combination Product (y/n): N
• PMA/PMN Number: K100638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• 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
• Device Lot Number: 1204126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Date Manufacturer Received: 01/20/2020
• Patient Sequence Number: 1