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 Problems Smoking (1585); Sparking (2595)

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

Event Date 08/23/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, the user¿s report was not confirmed.However, as noted in b5, the unit had smoking and sparking occur while testing.If additional information becomes available following the device evaluation, a supplemental report will be filed.

Event Description

The customer originally returned his olympus np2 workstation due to the unit experiencing an electrical issue.According to the initial reporter, the unit had intermittent power to the device during a therapeutic procedure.Reportedly, the intended procedure was completed using the subject device has only part of the workstation lost power.There was no patient harm reported as a result of this event.During the device evaluation, it was discovered that the unit had smoke, and sparks present during use.This report is being submitted to capture the smoking and sparking noted during the device evaluation.

Manufacturer Narrative

A review of the device history record found no deviations that could have caused or contributed to the reported issue.The following fields were updated: h4, h6 coding, h10.The following fields were corrected based on the information available at the time of the initial submissions: b3, and h6 component code.Additionally, a correction to g3 of the initial medwatch is being made.The aware date should be (b)(6) 2023.Based on the results of the investigation, it is likely that the root cause was user induced, in that the unit was repeatedly moved while connected to the wall supply which caused the mains lead to be pulled from the rear of the transformer causing both the minor arc damage and a disconnection of the mains supply from the transformer input.The event can be detected and prevented by handling the device in accordance with the instructions for use which warn against moving the workstation while connected and an indication to perform regular maintenance to identify any connector damage and replacement of the mains inlet lead if required.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: 17860018
• MDR Text Key: 324784872
• Report Number: 9611174-2023-00042
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/07/2023
• Initial Date FDA Received: 10/03/2023
• Supplement Dates Manufacturer Received: 01/17/2024
• Supplement Dates FDA Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2014
• 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