MAUDE Adverse Event Report: KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD WM-NP2 WORKSTATION SET 1 (JP); WM-*P2 SERIES OF ENDOSCOPY WORKSTATIONS

Model Number K10021766

Device Problem Smoking (1585)

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

Event Date 10/13/2023

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation at the time of this report.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

Event Description

The customer reported that the workstation outlet was burnt.The issue was found in preparation for use.It was reported that after replacing the 3-pin to 2-pin converter, a colon examination was performed, which was completed without any problems.There were no reports of harm.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was returned to olympus for inspection, and the customer's complaint was confirmed.The returned power cord was scorched.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 the cause of the scorched power cord is customer misuse by moving a connected workstation and/or withdrawing the wall plug, which is a deviation from the instructions for use (ifu).This is exacerbated by inadequate maintenance (regular inspection and replacement upon noting any defect of the plug - prior to this situation occurring).The occurrence of the reported problem can be prevented by adhering to the instructions for use (ifu) sections below: a) introducing a poor electrical contact path for the mains input supply (of an inherently high-power device ¿ the transformer) b) effectively ¿lifting¿ or defeating the protective grounding connection to the main supply.This is exceptionally worrying, and customer must be informed not to use such adaptors.Olympus will continue to monitor field performance for this device.

• Brand Name: WM-NP2 WORKSTATION SET 1 (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: 18088297
• MDR Text Key: 327567886
• Report Number: 9611174-2023-00046
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2024

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: K10021766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 01/31/2024
• Supplement Dates FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2017
• 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
• Treatment: CLV290.; CV-290.; GIF-XP290N.