MAUDE Adverse Event Report: KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. WM-NP1 100V JP; WM-*P1 SERIES OF ENDOSCOPY WORKSTATIONS

Model Number K10000284

Device Problems Misassembled (1398); Device Emits Odor (1425); Electrical Power Problem (2925)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 10/25/2019

Event Type  malfunction  

Manufacturer Narrative

It has been confirmed that there is no reported harm to either user or patient at this time the alleged complaint for "burning smell" cannot be confirmed however will be investigated when the device is returned.Reported in an abundance of caution.

Event Description

Following an examination there was a burning smell in the endoscope room.Burning smell is thought to have come from the workstation.

Manufacturer Narrative

The olympus keymed (okm) investigation has been completed.The outcome of the investigation was no fault found.The okm investigator was unable to reproduce the fault.There was no discoloration, carburisation or efflux of gasses from overheated or broken down components or joints.The transformer is twelve years old and has exceeded its expected service life of the workstation and transformer.This will be the final follow up report.If any new information is received the case will be reviewed.

• Brand Name: WM-NP1 100V JP
• Type of Device: WM-*P1 SERIES OF ENDOSCOPY WORKSTATIONS
• Manufacturer (Section D): KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.; keymed house, stock road; southend-on-sea, essex SS2 5 QH; UK SS2 5QH
• MDR Report Key: 9278278
• MDR Text Key: 177842722
• Report Number: 9611174-2019-00024
• Device Sequence Number: 1
• Product Code: FEM
• Combination Product (y/n): N
• PMA/PMN Number: CLASS 1
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: K10000284
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1