MAUDE Adverse Event Report: LINEMASTER SWITCH CORPORATION MULTIDEBRIDER FOOTSWITCH

Model Number MDFS100

Device Problem Defective Device (2588)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Device was inspected and determined that a faulty switch was observed.The switch is always ¿on¿ even the switch is not being press down.Device is non-repairable.Investigation is ongoing therefore the root cause cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that during an asset return inspection the device was found with faulty switch.There was no patient involvement on this event.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide the lot number and additional information based on the legal manufacturer¿s investigation.The following sections were updated: d4, d8, g3, g6, h2, h4, h6, and h10.Based on the legal manufacturer¿s investigation, the device history record (dhr) was reviewed and there were no problems found during the manufacturing of the device that would cause or contribute to the reported issue.The device met all specifications at the time of shipment.Olympus will continue to monitor the field performance of this device.

• Brand Name: MULTIDEBRIDER FOOTSWITCH
• Type of Device: MULTIDEBRIDER FOOTSWITCH
• Manufacturer (Section D): LINEMASTER SWITCH CORPORATION; 29 plaine hill road; woodstock CT 06281
• MDR Report Key: 11181359
• MDR Text Key: 233501490
• Report Number: 3003790304-2021-00014
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00821925027787
• UDI-Public: 00821925027787
• Combination Product (y/n): N
• PMA/PMN Number: K123429
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

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 Operator: Health Professional
• Device Model Number: MDFS100
• Device Lot Number: 342439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/18/2020
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 02/26/2021
• Supplement Dates FDA Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1