MAUDE Adverse Event Report: KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD WM-NP2 WORKSTATION SET 4 (US); WM-*P2 SERIES OF ENDOSCOPY WORKSTATIONS

Model Number	K10021611
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon further evaluation, service found normal wear and tear on the housing.The investigation is ongoing; therefore, a root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
The olympus demo asset device was sent in for inspection.There was no patient or user injury reported.Upon inspection and testing, service found the right castor was damaged.

• Brand Name: WM-NP2 WORKSTATION SET 4 (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 SS25Q H; UK SS25QH
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15848221
• Report Number: 9611174-2022-00034
• Device Sequence Number: 6429078
• Product Code: FEM
• UDI-Device Identifier: 15019778003191
• UDI-Public: 15019778003191
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2022

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: K10021611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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