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	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was loss of image.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Additional Manufacturer Narrative
Alleged failure: cib madeline, onsite , unit was called in back in april for the same issue of flickering to a black screen and then no signal color bars intermitently, (b)(4).*delay: about 20 min delay to get a new unit in [update - image was lost for a range of 1 to 20 seconds, flickering to no signal color bars and a black screen.Replacement device used to complete the procedure.] the failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause/s could be a bad camera cable, not fully seated s video or hdmi cable the product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that there was loss of image.

• 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: vijay menon ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 17476577
• Report Number: 0002936485-2023-00764
• Device Sequence Number: 7288787
• Product Code: OWN
• UDI-Device Identifier: 07613327174328
• UDI-Public: 07613327174328
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142310
• 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): 02/19/2024

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: 07/21/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2017
• 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