MAUDE Adverse Event Report: OLYMPUS KEYMED WM-NP2 WORKSTATION SET 1 (JP); WM-*P2 SERIES OF ENDOSCOPY WORKSTATIONS

Model Number K10021766

Device Problems Electrical /Electronic Property Problem (1198); Overheating of Device (1437); Smoking (1585)

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

Event Date 11/04/2022

Event Type  malfunction  

Manufacturer Narrative

Olympus keymed will further investigate the issue.

Event Description

After the inspection was completed, the outlet part of the power cable was burnt and smoke was coming out (there was no spark).No injury to patient or user reported.

Manufacturer Narrative

Okm investigation closed.Power cable had been discarded therefore no meaningful investigation possible by the legal manufacturer.Root cause is undeterminable.It has been confirmed that the cable has been replaced and the workstation is working correctly.

• Brand Name: WM-NP2 WORKSTATION SET 1 (JP)
• Type of Device: WM-*P2 SERIES OF ENDOSCOPY WORKSTATIONS
• Manufacturer (Section D): OLYMPUS KEYMED; the cordwainers; southend on sea, essex SS2 5 QH; UK SS2 5QH
• 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: 15851360
• MDR Text Key: 305681921
• Report Number: 9611174-2022-00035
• Device Sequence Number: 1
• Product Code: FEM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: CLASS 1
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/04/2022
• Initial Date FDA Received: 11/23/2022
• Supplement Dates Manufacturer Received: 02/08/2023
• Supplement Dates FDA Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/26/2015
• 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