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

Model Number WM-NP1

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 11/02/2016

Event Type  malfunction  

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 during the preparation for use in an unspecified procedure, the user of the healthcare facility inserted the power plug into the supply socket, a strange odour was noticed.The user removed the power plug from the supply socket and inserted it into another (second) power supply socket.Smoke occurred between the power plug and the second power supply socket.The user removed the power plug from the second power supply socket and the plug broke.Images supplied from olympus japan show the live pin of the plug is missing and there is scorching.There is no report of injury to patient or user and this report is submitted in an abundance of caution.

Manufacturer Narrative

Examination of high quality images supplied by olympus (b)(4) confirms a burned and broken "live" connection pin in the mains connector.From the image provided the upper most portion of the contact pin can clearly be seen to have ablated from the arcing present after the contact had broken.Deposits and heat damage from the arcing of this pin can also clearly be seen on the image of the wall power outlet socket.The cause of the event is mechanical stressing of the pins of the mains plug.The primary causes of mechanical stressing are "moving the workstation whilst plugged in", "running over the plug with the workstation" and "clinical staff treading on the mains lead or tripping on the mains lead".A clear instruction to the customer exists in the ifu requiring the customer to regularly inspect the mains plug and lead and to replace the mains lead at the first sign of damage to the connector or the lead.Consequently the root cause of this failure is the user disregarding this instruction to the customer in the ifu.If this instruction is disregarded this can lead to the failure of the mains connector described in this event.

• 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: 6126941
• MDR Text Key: 60870822
• Report Number: 9611174-2016-00006
• 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: 11/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2016
• 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: K10001332
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2009
• 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