MAUDE Adverse Event Report: KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD WM-NP2 WORKSTATION SET 2 (US); WM-*P2 SERIES OF ENDOSCOPY WORKSTATIONS

Model Number	K10021769
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to olympus by a biomedical engineer that a wm-np2 workstation¿s castor broke off.It is unknown when the reported issue was found.It is unknown when the reported issue was found.The device will not be returned due to the issue being resolved.There was no patient injury or adverse event reported to olympus.
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation as the reported issue was resolved.In general, the customer is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.Olympus will continue to monitor the field performance of this device.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final 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 5 years since the subject device was manufactured.Based on the results of the investigation, since the subject device was not returned to olympus for an evaluation and no images of the failure provided, the reported issue could not be confirmed.Although this is a known issue with this model workstation (fatigue fracture of the castor mounting spigot), the failure could not be verified.This supplemental report includes information added to h4.Olympus will continue to monitor field performance for this device.

• Brand Name: WM-NP2 WORKSTATION SET 2 (US)
• Common Device Name: WM-*P2 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: 17075069
• Report Number: 9611174-2023-00020
• Device Sequence Number: 15123172
• Product Code: FEM
• UDI-Device Identifier: 15019778004105
• UDI-Public: 15019778004105
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPTCLASS1
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2023

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: K10021769
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2023
• Supplement Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2018
• 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