MAUDE Adverse Event Report: LINEMASTER SWITCH CORPORATION MULTIDEBRIDER FOOTSWITCH

Model Number MDFS100

Device Problems Defective Component (2292); Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Olympus service site received a model mdfs100 with serial (b)(4) for the reported issue of damage to the cord.Evaluation determined that the reported issue was confirmed.A damaged insulation cable was observed on the device.The black foot pedal was determined to be broken.The left treadle was found to be on the down position.The device was noted to be non repairable.This mdr is being submitted retrospectively as part of a remediation effort related to the recent system, and process changes.A capa has been opened to manage the actions related to remediation of this issue, and any required reporting.

Event Description

It was reported that the device was found with damage to the cord.The reported issue occurred during an annual inspection of the biomedical engineer.There was no patient involvement on this reported event.No user harm, or injury reported.

Manufacturer Narrative

The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The root cause of damage to the cord could not be confirmed.The device undergoes a visual inspection for abnormalities prior to being shipped to the customer, it is likely that the footswitch was shipped free from damages, therefore damages incurred may have been as a result of transportation or use.Olympus will continue to monitor complaints for 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: 10684798
• MDR Text Key: 213708853
• Report Number: 3003790304-2020-00105
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K123429
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/13/2020

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: 297941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/09/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 10/30/2020
• Supplement Dates FDA Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1