MAUDE Adverse Event Report: KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LTD OLYMPUS; WM-WP1 MOBILE WORKSTATION

Model Number WM-WP1

Device Problems Thermal Decomposition of Device (1071); Loose or Intermittent Connection (1371); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 09/27/2016

Event Type  malfunction  

Manufacturer Narrative

Initial investigation by (b)(4) supplied high quality images to keymed ( medical & industrial equipment) ltd.The images were of the mains power supply cord and plug which connects into the main power supply, the outer socket cover of the mains socket, detached and pitted pin of the plug and a x-ray of the plug.A review of the serial number determined that the device was manufactured in 2006 making it over 10 years old.Examination of the x-ray image concurs a failure of the metal pin internal to the plug body.The live pin on the mains plug was broken inside the plug approximately 10 mm from the face of the plug and had been making tentative contact until pitting and charring had eroded the gap to such an extent that it no longer made contact.The broken pin is caused by mechanical stressing of the pins of the mains plug.There are a number of contributory causes of mechanical stressing determined during the investigations of previous similar events.The primary causes have been identified as "moving the workstation whilst still plugged in", "running over the plug with the workstation" and " clinical staff treading on the mains lead or tripping on the mains lead" the ifu instructs the user to regularly inspect the power supply cable and plug for excessive protrusion, twists, deformation or other irregularities.The root cause of this event failure is the user not following this instruction in the ifu requiring them to regularly inspect the mains plug and lead and to replace the mains lead at the first sign of damage to connector or lead.There is no report of injury to patient or user and this report is submitted in an abundance of caution.

Event Description

Olympus mobile workstations are intended for use in medical facilities under the direction of a trained physician and are designed to be used with a range of olympus equipment to facilitate gi endoscopy, endoscopic ultrasound, respiratory and surgical endoscopic procedures.Keymed ( medical & industrial equipment ) ltd have been made aware of an event whereby during the preparation for use for an unspecified procedure, a spark occurred from the power plug of the workstation (subject device), when staff from the user facility pressed the lamp button of the light source.A burnt deposit occurred at the hospital grade mains socket outlet.The power plug pin root had deteriorated when this event occurred.There was no report of injury to patient or user as a result of this event and this event is reported in an abundance of caution.

• Brand Name: OLYMPUS
• Type of Device: WM-WP1 MOBILE WORKSTATION
• Manufacturer (Section D): KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LTD; keymed house; stock road; southend on sea, essex SS2 5 QH; UK SS2 5QH
• Manufacturer (Section G): KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LTD; medical device manufacturing; centre, journeyman's way; temple farm industrial estate, essex SS2 5 TF; UK SS2 5TF
• Manufacturer Contact: alison prior ; keymed house; stock road; southend on sea, essex SS2 5-QH ; UK SS2 5QH ; 702616333
• MDR Report Key: 6089005
• MDR Text Key: 59621013
• Report Number: 9611174-2016-00005
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WM-WP1
• Device Catalogue Number: K10001332
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2006
• 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