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 Sparking (2595)

Patient Problems Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/16/2023

Event Type  malfunction  

Event Description

The customer reported that noise occurred on the screen when using the wm-np2 workstation set 4 with the visera elite ii video system center and endoeye flex deflectable videoscope during a therapeutic procedure.When the scope was pushed into the video system center connector three times without removing it, the customer got an electric shock with a spark.Noise on the screen disappeared due to static discharge and use of the device continued; however, the workstation also made a crackling sound and the screen blacked out.A replacement workstation was used to complete the procedure.There were no reports of burns or patient harm or impact due to this event.

Manufacturer Narrative

Reports are being submitted on the workstation, video system and videoscope.Please refer to the following event: patient identifier of (b)(6) is related to model number: k10021610, serial number: (b)(6).Patient identifier of (b)(6) is related to model number: otv-s300, serial number: (b)(6).Patient identifier of (b)(6) is related to model number: ltf-s190-10, serial number: (b)(6).Attempts to retrieve additional information from the customer are in progress.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Diligence was completed and no new information was received from the customer.The device was returned to olympus for inspection, and the customer's complaint was not confirmed.The power cable plug was bent, but it could be used normally.No abnormalities such as spark marks were found on the cable.When the device was connected to the otv-s300 and turned on, the central power supply started working normally.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely the event is related to the insertion of a piece of equipment into another piece of equipment, neither of which is the workstation or transformer.Since the device malfunction was not confirmed during evaluation, the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation since the mains plug and transformer was returned.The mains inlet plug had bent pins.There were no issues with the transformer.It is likely that there was a buildup of static charge on the operator.The previous root cause does not change.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: 17623279
• MDR Text Key: 321942252
• Report Number: 9611174-2023-00034
• 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,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2017
• 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