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	05/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has not bee returned to date.In addition, the investigation is ongoing; therefore, the root cause of the reported malfunction cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
The service center was informed that the workstation set had a broken wheel malfunction as the bolt snapped in half during an unspecified procedure.No patient or user injury was reported.
Additional Manufacturer Narrative
The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.Based on the information provided the probable cause of the broken castor is due to wear and tear.It is the understanding that this is the original castor on the workstation dated 2017.There is no evidence that regular servicing was carried out.The castor is considered a consumable item, it is also important that 6 monthly servicing is carried out on the castors, and the castors replaced if damage or wear is seen.In this case there is no evidence that this was carried out.The legal manufacturer will continue to monitor the field performance of this device.

• 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: 11980138
• Report Number: 9611174-2021-00018
• Device Sequence Number: 17278926
• Product Code: FEM
• UDI-Device Identifier: 15019778004105
• UDI-Public: 15019778004105
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2021

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: 05/17/2021
• Supplement Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 07/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1