MAUDE Adverse Event Report: KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD TC-C3 TROLLEY US SET 3; TC SERIES OF ENDOSCOPY WORKSTATIONS

Model Number	K10030136
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported the trolley us set 3 had a shock that occurred when unplugged.The issue occurred when moving the device at the customer facility.There were no reports of patient harm.
Additional Manufacturer Narrative
B5: additional information has been obtained and provided.This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 4 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, and the inability to evaluate the subject device, a definitive root cause of the reported event could not be identified.However, it¿s likely the cause is related to static accumulation, which then discharges through the operator or other individual moving the workstation.It is also possible that the operator, who reported receiving the shock, is generating a static charge on themselves which is then discharged rapidly through the workstation (via its own protective ground connection).This applies to when the workstation is being moved and connected to the main supply and touched by a statically charged individual.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The condition of the person that was involved in the event is stable/fine.A grounding chain was used to address the issue.

• Brand Name: TC-C3 TROLLEY US SET 3
• Common Device Name: TC SERIES OF ENDOSCOPY WORKSTATIONS
• Manufacturer (Section D): KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD; keymed house, stock road; southend on sea, essex SS25Q H; UK SS25QH
• Manufacturer (Section G): KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD; keymed house, stock road; southend on sea, essex
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20325379
• Report Number: 9611174-2024-00039
• Device Sequence Number: 12686908
• Product Code: FEM
• UDI-Device Identifier: 15019778007441
• UDI-Public: 15019778007441
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: CLASS1EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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
• Operator of Device: Health Professional
• Device Model Number: K10030136
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Race: White