MAUDE Adverse Event Report: KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) WM-DP2 WORKSTATION SET 1 (US); WM-*P2 SERIES OF ENDOSCOPY WORKSTATIONS

Model Number K10020639

Device Problem Power Problem (3010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2023

Event Type  Injury  

Event Description

The customer reported to olympus that there was no air and an intermittent black screen on the evis exera iii xenon light source during an unknown therapeutic procedure.There was no error message observed as a result of the failure.The procedure was moved to the next room to use a different wm-dp2 workstation set and later, the light source and evis exera iii video system center were plugged into the wall and started working.The condition of the patient was not impacted by the failure and the problem did not affect the outcome of the procedure.However, the procedure was delayed thirty minutes to troubleshoot.No medical intervention was required as a result of the reported problem.No additional patient harm was reported.The following medwatch reports are related: patient identifiers (b)(6) (wm-dp2 workstation set - this report) and (b)(6) (evis exera iii xenon light source).

• Brand Name: WM-DP2 WORKSTATION SET 1 (US)
• Type of Device: WM-*P2 SERIES OF ENDOSCOPY WORKSTATIONS
• Manufacturer (Section D): KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT); keymed house, stock road; southend-on-sea, essex SS25Q H; UK SS25QH
• MDR Report Key: 17102128
• MDR Text Key: 316951628
• Report Number: 2429304-2023-00188
• Device Sequence Number: 1
• Product Code: FEM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/22/2023,06/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: K10020639
• Device Lot Number: 21731924
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/22/2023
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/22/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CV-190 EVIS EXERA III VIDEO SYSTEM CENTER.; EVIS EXERA III XENON LIGHT SOURCE SN: (B)(6).
• Patient Outcome(s): Other