MAUDE Adverse Event Report: KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. WM-NP1 100V JP; WM-*P1 SERIES OF ENDOSCOPY WORKSTATIONS

Model Number K10000284

Device Problem Smoking (1585)

Patient Problem No Information (3190)

Event Date 09/05/2018

Event Type  malfunction  

Manufacturer Narrative

Event reported is that smoke occurred from the bottom of the workstation.Photographic evidence shows damaged electrical connector inside the casing of the transformer.No report of injury to patient or user.Okm have requested that the product is returned for further investigation.Reported in the abundance of caution.

Event Description

Smoke occurred from bottom of workstation.

Manufacturer Narrative

Olympus (b)(4) investigation has been completed.Outcome of investigation was the event was caused due to incorrect repair or maintenance of the equipment.Repair and maintenance records were requested but this information was unavailable.As stated previously there was no report of injury to patient or user.This will be the final follow up report, however, if any new information is received the case will be re-opened.

• Brand Name: WM-NP1 100V JP
• 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: 7913479
• MDR Text Key: 122156724
• Report Number: 9611174-2018-00016
• 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
• Type of Report: Initial,Followup
• Report Date: 10/22/2018

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: No Information
• Device Model Number: K10000284
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/05/2018
• Initial Date FDA Received: 09/27/2018
• Supplement Dates Manufacturer Received: 10/16/2018
• Supplement Dates FDA Received: 10/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1