MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE VISIONPRO 26" LED DISPLAY INTERNATIONAL KIT; CAMERA, TELEVISION, SURGICAL, WITHOUT AUDIO

Model Number	0240031020
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that there was image loss during procedure.Please note that the procedure was completed successfully.
Event or Problem Description
It was reported that there was image loss during procedure.Please note that the procedure was completed successfully.
Additional Manufacturer Narrative
The device was received at the local service facility for investigation.The technical service report is attached (see comm log), and indicates: the reported event is confirmed.The visionpro display under test power up initially showing a normal image but then the image turns black while the power led and backlight remains on.If left on, the image returns to normal and becomes black again at random intervals.The faulty visionpro display will be discarded and replaced with a new one.Faulty mode - faulty display faulty cause - faulty monitor probable root cause: ¿ display main board / sub board ¿ connectors/ cables ¿ display firmware ¿ display power supply ¿ display lcd panel ¿ use error ¿ electromagnetic interference (emi) from rf communication, hf surgical instruments, esd, or power surge ¿ manufacturing/ service nonconformity the reported failure mode will be monitored for future reoccurrence.

• Brand Name: VISIONPRO 26" LED DISPLAY INTERNATIONAL KIT
• Common Device Name: CAMERA, TELEVISION, SURGICAL, WITHOUT AUDIO
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9777518
• Report Number: 0002936485-2020-00106
• Device Sequence Number: 3267917
• Product Code: FWB
• UDI-Device Identifier: 07613327056082
• UDI-Public: 07613327056082
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

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
• Operator of Device: Health Professional
• Device Model Number: 0240031020
• Device Catalogue Number: 0240031020I
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1