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

Model Number WM-NP1

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 05/10/2016

Event Type  malfunction  

Manufacturer Narrative

Device was manufactured in 2006.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.Device awaiting return of device.

Event Description

The olympus wm-np1 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, endoscopy 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 threaded stud of the right rear castor of the workstation broke when the workstation was manoeuvred.The workstation was caught by healthcare facility staff.There is no report of injury to patient or users and this report is submitted in an abundance of caution.

Manufacturer Narrative

Investigation based on the return of the workstation castor to the manufacturer.The workstation was manufactured in 2006.The most probable cause identified by the investigating engineer was that the castor washer inside diameter was not sufficient to accomodate the castor stem.The inside diameter of the washer was increased by 0.3mm following a design review in 2007.

• 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: 5722919
• MDR Text Key: 47829859
• Report Number: 9611174-2016-00002
• Device Sequence Number: 1
• Product Code: FEM
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2016
• 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: K1000287
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1