MAUDE Adverse Event Report: KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LTD OLYMPUS; WM-NP1 MOBILE WORKSTATION

Model Number WM-NP1

Device Problem Smoking (1585)

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

Event Date 05/10/2016

Event Type  malfunction  

Manufacturer Narrative

Device was manufactured in 2008.Olympus (b)(4) plan to return the subject device to the manufacturer - keymed (medical & industrial equipment) ltd for investigation.Keymed have requested a copy of the maintenance records from the healthcare facility and any service events at the olympus repair centre.The healthcare facility had recently undertaken replacement construction works for the wall outlet socket.

Event Description

The olympus wm-p1 series mobile workstation is intended for use in medical facilities under the direction of a trained physician and has been 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 has been made aware of an event which took place in (b)(6).The physician had completed a diagnostic large bowel endoscopy procedure, when he noticed an abnormal smell and found white smoke coming from the connection between the plug of the subject device and the wall outlet socket.Facility staff pulled the plug out of the wall socket, the plug broke and left residue in the wall outlet socket.There is no report of injury to patient or user and this report is submitted in an abundance of caution.

Manufacturer Narrative

Device was not returned to the manufacturer, however images of the power cord plug and broken pin were provided to the manufacturer for investigation purposes.Images of the fault are consistent with the failures see previously - whereby mechanical stressing of the pins has occurred, consistence with use error (eg moving the workstation whilst plugged in).Olympus (b)(4) provided the following information: the healthcare facility performed 'prior-to-use' checks on the subject device, no maintenance records were available for the subject device.There have been no service events recorded at the olympus (b)(4) service centre for the subject device.It had been previously reported that the healthcare facility had recently undertaken replacement construction works for the wall outlet socket.Subsequent information has confirmed that the healthcare facility replaced the cover and the socket of the outlet.The healthcare facility did not change the wiring.Ifu instructs the customer to inspect and replace mains lead at the first sign of damage to the connector or lead.

• Brand Name: OLYMPUS
• Type of Device: WM-NP1 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: 5700532
• MDR Text Key: 47903829
• Report Number: 9611174-2016-00003
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WM-NP1
• Device Catalogue Number: K10000284
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2008
• 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