MAUDE Adverse Event Report: KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. WM-NP2 WORKSTATION SET 1 (JP); WM-*P2 SERIES OF ENDOSCOPY WORKSTATIONS

Model Number K10021766

Device Problems Thermal Decomposition of Device (1071); Loss of Power (1475); Unexpected Shutdown (4019)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2021

Event Type  malfunction  

Manufacturer Narrative

Olympus keymed requested that the faulty power cable was returned for further investigation.On 01 april 2021 olympus keymed were advised that the faulty power cable had been discarded.Keymed investigation will be completed on information and photos provided.

Event Description

The power to the workstation turned off during a procedure.The workstation was restarted and the power returned.The procedure was completed.A service was carried out on (b)(6) 2021, it was found that the power cord to the transformer was burnt.There was no injury to patient or user.

Manufacturer Narrative

Olympus keymed investigation completed.Outcome of investigation concluded that the failure was caused by miss-use (moving the workstation while still being plugged in to the wall socket) and lack of routine maintenance.H3 other text: the part had been discarded.

• Brand Name: WM-NP2 WORKSTATION SET 1 (JP)
• Type of Device: WM-*P2 SERIES OF ENDOSCOPY WORKSTATIONS
• Manufacturer (Section D): KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.; keymed house, stock road; southend-on-sea, essex SS2 5 QH; UK SS2 5QH
• MDR Report Key: 11617889
• MDR Text Key: 245607148
• Report Number: 9611174-2021-00011
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: K10021766
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1