MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 1588 AIM CAMERA CONTROL UNIT (CCU); CONFOCAL OPTICAL IMAGING

Catalog Number	1588010000
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was dark of image.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that there was dark of image.
Additional Manufacturer Narrative
Alleged failure: eib alexa, onsite.During ent sinus cases sometimes the picture has been getting really dark.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.Probable root causes are: bad digital board.Advise to replace the digital board.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• Brand Name: PKG, 1588 AIM CAMERA CONTROL UNIT (CCU)
• Common Device Name: CONFOCAL OPTICAL IMAGING
• 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: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 19293330
• Report Number: 0002936485-2024-00377
• Device Sequence Number: 8687011
• Product Code: OWN
• UDI-Device Identifier: 07613327174328
• UDI-Public: 07613327174328
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K142310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

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: 1588010000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2016
• 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