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

Model Number 225023

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4). Investigation summary: according to the information provided, it was reported that a blind device received in decontamination site on 08/20/2020 with no complaint information attached and could not be associated with an existing complaint. The complaint device was received and inspected. Visual observations revealed that the device was worn. Also, it had marks of corrosion. Besides, the button was broken and without its cap. To test its functionality, the device was connected to a vapr vue generator and was set to maximum power for ablation and coagulate test and it did not work for any modes. The possible route cause for the findings could be related to fair wear and tear due to age; as well as rough use. As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required. 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. Udi: (b)(4).

Event Description

It was reported a blind device received in decontamination site on (b)(6) 2020 with no complaint information attached and could not be associated with an existing complaint.

• Type of Device: FOOT-SWITCH, ELECTRICAL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 10690198
• MDR Text Key: 211762700
• Report Number: 1221934-2020-03031
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• PMA/PMN Number: K041135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 09/29/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 225023
• Device Catalogue Number: 225023
• Device Lot Number: 1901172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage