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

Model Number 225023

Device Problems Corroded (1131); Mechanical Jam (2983); Physical Resistance/Sticking (4012)

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

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: udi: (b)(4).Investigation summary: the device was received at the service center.It was reported that the fault code 600 ref 20 is occurring frequently.Per service reports, this complaint can be confirmed.A preliminary visual evaluation was performed and rust on the foot pedal cut side was observed.However, the device was found to be irreparable and was returned to the customer without repair, hence is unavailable for further evaluation.The faulty parts was identified as the root cause for the device failure during the service evaluation.A manufacturing record evaluation was performed for the finished device lot number (1805051), and no non-conformance was 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: an mre review was performed and results obtained as below: anomalies or discrepancies (non-conformance): none.

Event Description

It was reported from the affiliate that the vapr3 footswitch device stuck (fault code 600 ref 20) was occurring frequently even after re-starting.When restarting, the evaporation (yellow) foot switch was stepped on, but it moved while blinking.The state continued, and when the hemostatic (blue) foot switch was stepped on, the hemostatic mode was entered only then.However, it remained in transpiration mode without stepping on any footswitch.During an in-house engineering evaluation, it was determined that the device had rust on the foot pedal on the cut side was observed.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.The exact date of this event was unknown but was noted to have occurred in 2021.There were no adverse patient consequences reported.No additional information was provided.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H10 additional narrative: all medical device reports associated with the same/similar device(s) and reported condition of ¿corrosion/rusting/pitting¿ were reviewed.It was determined that ¿corrosion/rusting/pitting¿ has not caused or contributed to any deaths or serious injuries within the reviewed time period of january 1, 2018- july 1, 2022.Based on the reviewed data, the likelihood of a death or serious injury occurring as a result of ¿corrosion/rusting/pitting¿ is remote; therefore, ¿corrosion/rusting/pitting¿ associated with same/similar device(s) of this report will no longer be reported as a medical device report (mdr) unless the event results in a reportable event per 21 cfr 803.50.

• 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: 12370777
• MDR Text Key: 268248531
• Report Number: 1221934-2021-02562
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705009114
• UDI-Public: 10886705009114
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K041135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 225023
• Device Catalogue Number: 225023
• Device Lot Number: 1805051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1