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

Model Number	1588010000
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2021
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 the case was canceled after the patient was prepped and under anesthesia.
Additional Manufacturer Narrative
The device manufacturer date is not known.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: camera box useless/broken probable root cause: cables, connectors, digital board, power supply, filter / fuse, ac inlet board main board, transition board, fiber board, intermittence between transition board and ch connector, software, scope, light source, camera head, couple, 1488 & 1588 extension cable, intermittence while using rf devices, problem toggling light source or from camera head, connected monitors, leaking, use error, poor grounding, electromagnetic interference (emi) from rf communication, hf surgical instruments, esd, or power surge, manufacturing/ service nonconformity.The reported failure mode will be monitored for future reoccurrence.H3 other text : 81.
Event or Problem Description
It was reported that the case was canceled after the patient was prepped and under anesthesia.

• 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
• MDR Report Key: 11978006
• Report Number: 0002936485-2021-00310
• Device Sequence Number: 13718203
• Product Code: OWN
• UDI-Device Identifier: 07613327174328
• UDI-Public: 07613327174328
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K142310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1588010000
• Device Catalogue Number: 1588010000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 07/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other