MAUDE Adverse Event Report: KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD WM-260 100V-JP; WM-*P1 ENDOSCOPY WORKSTATION

Model Number K7503878

Device Problem Sparking (2595)

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

Event Date 07/31/2023

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation.If additional information becomes available prior to the conclusion of the investigation, a supplemental report will be filed.

Event Description

The customer reported that his olympus wm-260 was producing sparks from the power cord during procedure preparation.According to the initial reporter, the intended procedure was completed using a similar device with no impact to the patient.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it can be presumed that the following is what led to the event in question: an inductive load is connected to (or more significantly disconnected from) a power supply then a surge current is created.In the case of disconnection, the collapsing magnetic field which is present in the inductive transformer core of our transformer units will discharge it's energy by creating a current flow.This is caused by creating (for practical purposes, almost without limit) a voltage which will overcome the resistance of the air and generate an arcing discharge.This is an expected behavior of inductive components and is mitigated against in the okm transformer designs.This mitigation takes the form of anti-surge circuitry included in the design and of guidance in the instructions for use (ifu) which contraindicate using the mains connector plug as (essentially) a mains switch.However, sometimes users move workstations with the mains connector inserted into a wall supply.This can lead to a partial removal of the plug from the wall if the cable is stretched or pulled during movement.Each subsequent disconnection cumulatively damages the connector.A similar (though lesser severe) mechanism exists upon connection, though the instantaneous energy is limited by the capacity of the supply (whereas on disconnection it is effectively only limited by the winding resistance of the inductive component).Three attempts were performed to obtain additional information, but no response was received from the customer.Olympus will continue to monitor field performance for this device.

• Brand Name: WM-260 100V-JP
• Type of Device: WM-*P1 ENDOSCOPY WORKSTATION
• 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: 17564257
• MDR Text Key: 321337615
• Report Number: 9611174-2023-00032
• Device Sequence Number: 1
• Product Code: FEM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: K7503878
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2008
• 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