MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 1688 AIM 4K INLINE CAMERA HEAD, C-MOUNT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	1688710105
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2022
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 a potential of adverse consequences due to loss of image.
Event or Problem Description
It was reported that there was a potential of adverse consequences due to loss of image.
Additional Manufacturer Narrative
The product was not returned for investigation and the reported failure mode was not confirmed.Alleged failure: blurry.Probable root cause: cables, hdmi cables, connectors, digital board, power supply, filter / fuse, ac inlet board, main board, transition board, intermittence between transition board and ch connector, software, camera head, coupler, problem toggling light source, connected monitors, leaking, poor grounding, no/incorrect communication with light source, soaking cap disconnection during sterilization, electromagnetic interference (emi) from rf communication, hf surgical instruments, esd, or power surge, cybersecurity attack, pendulum ch inertial measurement unit, use error.The failure mode will be monitored for future reoccurrence.H3 other text : 81.

• Brand Name: PKG, 1688 AIM 4K INLINE CAMERA HEAD, C-MOUNT
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: benjamin ly ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 13551683
• Report Number: 0002936485-2022-00094
• Device Sequence Number: 4433537
• Product Code: GCJ
• UDI-Device Identifier: 07613327419009
• UDI-Public: 07613327419009
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K182160
• 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): 04/07/2022

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: 1688710105
• Device Catalogue Number: 1688710105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2022
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2020
• 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