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

Catalog Number	0240031020
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the monitor fell.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
It was reported that the monitor fell.
Additional Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore, the reported failure mode was not confirmed.Alleged failure: monitor falling.Probable root cause: display design.Mounting mechanism breaks.Use error.Manufacture date is not known.

• Brand Name: PKG, VISIONPRO 26" LED DISPLAY
• Common Device Name: CAMERA, TELEVISION, SURGICAL, WITHOUT AUDIO
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: benjamin ly ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 17611504
• Report Number: 0002936485-2023-00859
• Device Sequence Number: 6712831
• Product Code: FWB
• UDI-Device Identifier: 07613327056082
• UDI-Public: 07613327056082
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2024

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 Catalogue Number: 0240031020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown