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 Failure to Power Up (1476); Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/17/2017

Event Type  malfunction  

Event Description

When the device was moved after the endoscopy was completed, the user found that the subject device wm-np1 could not be turned on.After that, the user found that the smoke was generated from the outlet socket of the user facility where the power cord of the subject device wm-np1 was connected.There was no report of the patient¿s injury or user¿s injury regarding this event.

Manufacturer Narrative

Power cable not returned for investigation.Investigation carried out on information and images provided by olympus (b)(4).The images show the plug pins are discoloured and bent, consistent with the plug not being fully inserted into the power socket / workstation being manoeuvred whilst plugged into the power socket.The instructions for use contain warning notes instructing the user to take the necessary steps to avoid the cable becoming taut, both to avoid damage to the mains cable or plug (and to avoid creating a trip hazard).This will be submitted as the final report, however if any new information is provided the complaint will be re-opened.No report of injury to patient nor user.This report is submitted in an abundance of caution.

• 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
• Manufacturer (Section G): KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LTD; medical device manufacturing; centre, journeymann's way; southend on sea
• Manufacturer Contact: alison prior ; keymed house, stock road; southend on sea, essex ; 0441702616
• MDR Report Key: 6590366
• MDR Text Key: 76060973
• Report Number: 9611174-2017-00003
• Device Sequence Number: 1
• Product Code: FEM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/05/2018

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: No Information
• Device Model Number: K10000284
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/17/2017
• Initial Date FDA Received: 05/25/2017
• Supplement Dates Manufacturer Received: 04/04/2018
• Supplement Dates FDA Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1