MAUDE Adverse Event Report: KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LTD OLYMPUS; WM-NP2 MOBILE WORKSTATION

Model Number WM-NP2

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)

Event Date 09/27/2016

Event Type  malfunction  

Manufacturer Narrative

Initial investigation by olympus (b)(4) determined that the subject device (castor) had many scratches and that the paint was coming off.Olympus (b)(4) were advised that on average the user facility moved the workstsation 5 times a week - the movement distance being between 10m to 20m.

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 endoscope procedures.Keymed ( medical & industrial equipment) ltd have been made aware of an event whereby a castor on a wm-np2 workstation broke when healthcare facility staff moved the workstation after a procedure.There is no report of injury to patient or user, this event did not cause any of the devices on the workstation to fall and therefore this report is submitted in an abundance of caution.

Manufacturer Narrative

High quality images supplied by olympus (b)(4) show a dark wearing on the bolt clamping face which indicates that the castor bolt came loose before shearing.The images also show that the unthreaded section of the castor mounting stud seems to be longer than specified by the manufacturer, plus the image also shows some scoring of the unthreaded section.The unthreaded section being longer than specified would prevent the castor from being fully seated before the castor insertion tool torques out, thus leading the operator to thinking that the castor had been correctly installed and would account for the scoring marks.If the castor had not been fully seated it has a much greater chance of unwinding and increasing the gap, with any seating gap providing a weak point for the castor mounting.This weak point would make the castor more vulnerable to breaking through impact or shockload.Since the manufacture of the subject device, the base design of the workstation has been updated from a steel box frame design with castor mounting bosses to a solid metal strut with mounting washers.This later design with the 5mm thick mounting washers has much more margin for the castors with untreaded sections outside of the specification and since its introduction in april 2014 no castor failures of this nature have been recorded.

• Brand Name: OLYMPUS
• Type of Device: WM-NP2 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: 6185023
• MDR Text Key: 63198329
• Report Number: 9611174-2016-00007
• 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,Followup
• Report Date: 09/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WM-NP2
• Device Catalogue Number: K10021610
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/27/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/15/2013
• 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
• Treatment: CARBON DIOXIDE BOTTLE; CLV-S190 LIGHT SOURCE; HVO-1000MD VIDEO RECORDER; OEV261H MONITOR; OTV-190 VIDEO PROCESSOR; TOUCH PANEL FOR HVO-1000MD; UHI-4 INSUFFLATION UNIT