MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 1788 4K MICROSCOPE CAMERA HEAD; MICROSCOPE, SURGICAL

Catalog Number	1788210080
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Fogging (1253)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
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 foggy image.
Additional Manufacturer Narrative
Alleged failure: foggy image.Confirmed failure: pressure check - no leak.Incoming analysis - npa.Service codes - ch-npf.Probable root cause: moisture ingress in ch or coupler.Moisture ingress in ch/coupler junction.Poor heat conduction for optical components.Faulty communication with light source.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that there was foggy image.

• Brand Name: PKG, 1788 4K MICROSCOPE CAMERA HEAD
• Common Device Name: MICROSCOPE, SURGICAL
• 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: 19084507
• Report Number: 0002936485-2024-00310
• Device Sequence Number: 7576106
• Product Code: EPT
• UDI-Device Identifier: 07613327580020
• UDI-Public: 07613327580020
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2024

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: 1788210080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2024
• Supplement Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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