MAUDE Adverse Event Report: KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. WM-NP2 WORKSTATION SET 1 (US); WM-*P2 SERIES OF ENDOSCOPY WORKSTATIONS

Model Number	K10021764
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned for evaluation,user will order and replace the defective wheel.The cause of the reported event cannot be determined.The investigation is ongoing and if additional information is received this report will be supplemented accordingly.
Event or Problem Description
The service center was informed that the castor wheel broke off the workstation.There was no user/patient injury reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.Based on the results of the legal manufacturer's investigation, the castors are considered consumable items and according to the service manual, 6 month inspection is required to access the quality of castors.If damage / wear is seen, then the castors are required to be replaced.In this case, the castors are dated 2019.If additional applicable information is identified, a supplemental report will be filed.

• Brand Name: WM-NP2 WORKSTATION SET 1 (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 SS2 5 QH; UK SS2 5QH
• MDR Report Key: 11587947
• Report Number: 9611174-2021-00009
• Device Sequence Number: 19860647
• Product Code: FEM
• UDI-Device Identifier: 15019778004105
• UDI-Public: 15019778004105
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2021

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: K10021764
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1