MAUDE Adverse Event Report: NDS SURGICAL IMAGING, LLC RADIANCE; CAMERA, SURGICAL AND ACCESSORIES

Model Number	90X0695
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
We have been informed of the following event: "reported problem: the monitor's glass screen fell off and shattered.Was previously repaired on rma# 200261754 involving the lcd screen.".
Additional Manufacturer Narrative
We have received the display without the shattered front glass pieces.Hence, the investigation of the glue rests on the shattered pieces was not possible in order to establish the root cause.
Additional Manufacturer Narrative
We have received the display without the shattered front glass pieces.Hence, the investigation of the glue rests on the shattered pieces was not possible in order to establish the root cause.Additionally, we have reviewed the production records (dhr).No anomalies were detected.

• Brand Name: RADIANCE
• Common Device Name: CAMERA, SURGICAL AND ACCESSORIES
• Manufacturer (Section D): NDS SURGICAL IMAGING, LLC; 100 paramount drive; suite 101; sarasota FL 34232
• Manufacturer (Section G): NDS SURGICAL IMAGING, LLC; alte poststrasse 11; ludwigsstadt 96337 ; GM 96337
• Manufacturer Contact: emilia dürr ; 100 paramount drive; suite 101; sarasota, FL 34232
• MDR Report Key: 17937871
• Report Number: 3014991167-2023-00001
• Device Sequence Number: 11486325
• Product Code: KQM
• UDI-Device Identifier: 00818089021188
• UDI-Public: 00818089021188
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2023

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 Model Number: 90X0695
• Device Catalogue Number: 90X0695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown