MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION VISERA 4K UHD LIGHT SOURCE; ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM

Model Number CLV-S400

Device Problems Connection Problem (2900); Activation, Positioning or Separation Problem (2906)

Patient Problem Insufficient Information (4580)

Event Date 06/14/2021

Event Type  malfunction  

Event Description

There is a small switch in the light source to active the high intensity mode, to do this a collar needs to engage.The collar does not seem to be thick enough to maintain engagement with the switch.When the users rests the light cable at an angle [often its natural resting location] this small movement can cause the high intensity light switch to disengage [possible design issue with this light source].This is happening with increasing frequency and has caused a delay in operating room start time.Age of the light sources: (b)(4)  incoming date 10/18/2017, (b)(4)  incoming date 10/18/2017 (b)(4)  incoming date 07/01/2019, (b)(4)  incoming date 05/05/2021.Fda safety report id# (b)(4).

• Brand Name: VISERA 4K UHD LIGHT SOURCE
• Type of Device: ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION
• MDR Report Key: 12016367
• MDR Text Key: 257212707
• Report Number: MW5101929
• Device Sequence Number: 2
• Product Code: NWB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/15/2021
• 4 Devices were Involved in the Event: 1 2 3 4

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: CLV-S400
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/16/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1