MAUDE Adverse Event Report: KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD WM-NP3 MOBILE WORKSTATION ROW GI; WM-*P3 SERIES OF ENDOSCOPY WORKSTATIONS

Model Number	K10035368
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the mobile workstation had a broken castor.There were no reports of patient harm.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Correction is being made to previously submitted e1 - initial reporter address, which was not late.The correct initial reporter was internal to olympus.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over three (3) years since the subject device was manufactured.The device was not returned to olympus for inspection, and the customer's complaint/reportable malfunction was not confirmed.Based on the results of the investigation, a definitive root cause could not be determined.No item was available for return for a complete and meaningful investigation.Likewise, no image of the castor could be provided.However, from the narrative provided, olympus presumes the most likely cause of this particular failure is metal fatigue, provoked by multiple impacts.This occurs following the development of a stress crack in the mounting spigot, due to an unknown origin, that propagates through the spigot driven by the additional stresses now being placed on the component.This propagation eventually causes a loss of pre-tension in the threaded joint and the castor works loose.This continued loosening expedites the rate of cracking until the effective cross-sectional area of the castor mounting spigot is reduced to such an extent, that inevitably, a complete brittle fracture of the castor spigot occurs, often without warning and with a seemingly innocuous load being applied.There are several potential known causes of the crack origin but non-availability of either part of the broken castor spigot prevents further investigation.
Event or Problem Description
The issue occurred with the front right braked castor.The failure was found during inspection in loaner center when it was returned from the customer.

• Brand Name: WM-NP3 MOBILE WORKSTATION ROW GI
• Common Device Name: WM-*P3 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: 20547005
• Report Number: 9611174-2024-00044
• Device Sequence Number: 7541366
• Product Code: FEM
• UDI-Device Identifier: 15019778007854
• UDI-Public: 15019778007854
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2024

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: Other
• Device Model Number: K10035368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2024
• Supplement Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2021
• 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: Unknown