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

Model Number	1588010000
Medical Device Problem Codes	No Display/Image (1183); Poor Quality Image (1408)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2021
Type of Reportable Event	Malfunction
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 there was loss of visualization.
Additional Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: poor quality video output probable root cause: incorrect / inadequate coupler lens coating.Use error.Inactive aim compatible light source laser.Software.Main board.Manufacturing/ service nonconformity.Scope.Use of third party usb cable to connect 1588 ccu to l10.Electromagnetic interference (emi) from rf communication, hf surgical instruments, esd, or power surge.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text : 81.
Event or Problem Description
It was reported that there was loss of visualization.

• Brand Name: 1588 AIM CAMERA CONTROL UNIT (CCU) - INTERNATIONAL KIT
• Common Device Name: CONFOCAL OPTICAL IMAGING
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 12345476
• Report Number: 0002936485-2021-00450
• Device Sequence Number: 14352893
• Product Code: OWN
• UDI-Device Identifier: 07613327174328
• UDI-Public: 07613327174328
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 10/06/2021

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: 1588010000
• Device Catalogue Number: 1588010000I
• Device Lot Number: FRD-1588CCU-1-001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 08/19/2021
• Supplement Report FDA Received Date: 10/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1