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	Intermittent Loss of Power (4016)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2021
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 image.
Event or Problem Description
It was reported that there was loss of image.
Additional Manufacturer Narrative
The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.The technical service report is attached (see comm log), and indicates: the 1588 ccu has been repaired and passed our quality inspection procedure.The following items were replaced on the unit: front board.Transition board.Digital board.Ac inlet board.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.Coupler.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.

• 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: 12269403
• Report Number: 0002936485-2021-00415
• Device Sequence Number: 17278762
• Product Code: OWN
• UDI-Device Identifier: 07613327174328
• UDI-Public: 07613327174328
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2021

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: 1588010000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2011
• Initial Date Received by Manufacturer: 07/05/2021
• Supplement Date Received by Manufacturer: 07/05/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 10/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1