MAUDE Adverse Event Report: KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. WM-W260 110-120V US; WM-*P1 SERIES OF ENDOSCOPY WORKSTATIONS

Model Number K7505190

Device Problem Smoking (1585)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 06/19/2018

Event Type  malfunction  

Manufacturer Narrative

Olympus keymed have requested the return of the product for further investigation.No report of injury to patient or user.Reported in an abundance of caution.A follow-up report will be provided with additional information once investigation has been completed.

Event Description

Event translated from (b)(6) using (b)(6) translate: during inspection, smoke was generated from the workstation (wm - 260).The inspection was completed by replacing the workstation.There were no reports of injury to patients or medical staff.The product has had a considerably long service life, and the event occurred due to the age of the product.

Manufacturer Narrative

Keymed investigation has been completed.Product is confirmed to have been manufactured in 2003, which is beyond the expected service life of the product.Product was not returned for further investigation and conclusion of investigation was drawn from similar modes on previous investigations.Outcome of investigation - event linked to no or limited repair or maintenance of the equipment which has been alleged to be caused by the fuse holder.No user or patient was harmed from this complaint.This will be the final follow up report, however, if the product is returned or further information provided the pae will be reopened and investigated further.

• Brand Name: WM-W260 110-120V US
• Type of Device: WM-*P1 SERIES OF ENDOSCOPY WORKSTATIONS
• Manufacturer (Section D): KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.; keymed house, stock road; southend-on-sea, essex
• MDR Report Key: 7637034
• MDR Text Key: 112721810
• Report Number: 9611174-2018-00010
• Device Sequence Number: 1
• Product Code: FEM
• Combination Product (y/n): N
• PMA/PMN Number: CLASS 1
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: K7505190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/19/2018
• Initial Date FDA Received: 06/26/2018
• Supplement Dates Manufacturer Received: 09/07/2018
• Supplement Dates FDA Received: 09/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1