MAUDE Adverse Event Report: BLACK DIAMOND VIDEO 31" VIVIDIMAGE 4K SURGICAL DISPLAY

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/14/2021

Event Type  malfunction  

Manufacturer Narrative

The evaluation of the monitors subject of the event are in process.A follow-up mdr will be submitted when additional information becomes available.

Event Description

The user facility reported that during a patient procedure the monitor went black on two of their 31" vividimage 4k surgical displays.Facility personnel brought in a mobile monitor to complete the procedure resulting in a procedure delay.The procedure was completed successfully.No report of injury.

Manufacturer Narrative

The technician arrived onsite to inspect the 31" vividimage 4k surgical displays and found them to be operating properly; no repairs were required.It appears that the karl storz camera being used was the cause of the reported event as no issues with the function or operation of the 31" vividimage 4k surgical displays were identified.Steris is not the manufacturer or distributor of the karl storz camera.Steris notified the manufacturer, karl storz, of the reported event to internally investigate and evaluate for reportability in accordance with 21 cfr part 803 and health canada reporting guidelines.No additional issues have been reported.

• Brand Name: 31" VIVIDIMAGE 4K SURGICAL DISPLAY
• Type of Device: SURGICAL DISPLAY
• Manufacturer (Section D): BLACK DIAMOND VIDEO; 503 canal blvd.; richmond CA 94804
• MDR Report Key: 12168095
• MDR Text Key: 261547894
• Report Number: 3008776287-2021-00003
• Device Sequence Number: 1
• Product Code: KQM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1