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

Model Number K10021610

Device Problem Smoking (1585)

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

Event Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.E1: (b)(6) hospital.

Event Description

The customer reported to olympus that the wm-np2 workstation set 4 (jp) had smoke come out from the power outlet.The event occurred during preparation for use.There was no patient harm associated with the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Additionally, (h4) device manufacturing date was added.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 8 years since the subject device was manufactured.Based on the results of the investigation and the information provided, though the specific root cause could not be confirmed, the reported issue is consistent with a use issue where an inductive load was connected/disconnected from the power supply while the power was on and plugged in to mains/ac power.When this occurs, a surge current is created.The power supply discharges the surge energy by creating a voltage which will overcome the resistance of the air and generate an arcing discharge (spark and/or smoke).This is expected behavior and is mitigated by the surge protection circuit included in the power supply design and by the guidance provided in the instructions for use (ifu), installation/maneuvering/inspection and maintenance.However, sometimes users still move workstations with the power supply connected to mains.If the cable is stretched or pulled during movement, the plug may be partially or fully removed inadvertently.Each occurrence further damages the power supply mains input connector.The event can be detected/prevented by following the ifu: wm-np2 instruction manual sections: 4.9 equipment installation, 5.2 maneuvering, 6.2 inspection and 6.4 maintenance.Olympus will continue to monitor field performance for this device.

• Brand Name: WM-NP2 WORKSTATION SET 4 (JP)
• Type of Device: 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: 18397254
• MDR Text Key: 331712835
• Report Number: 9611174-2023-00053
• Device Sequence Number: 1
• Product Code: FEM
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/22/2024

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
• Device Operator: Health Professional
• Device Model Number: K10021610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/10/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 01/12/2024
• Supplement Dates FDA Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1