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

Catalog Number	1688610122
Medical Device Problem Codes	Poor Quality Image (1408); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
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 poor image quality.
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 image output.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 (imu); incident light from surgical scene is reflected by coupler/ch window; use error.The product was returned for investigation and the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that there was poor image quality.

• Brand Name: PKG 1688 AIM 4K CAMERA HEAD WITH INTEGRATED COUPLER
• 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: 20052286
• Report Number: 0002936485-2024-00594
• Device Sequence Number: 20816767
• Product Code: GCJ
• UDI-Device Identifier: 07613327418996
• UDI-Public: 07613327418996
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K182160
• 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): 11/06/2024

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: 1688610122
• Device Lot Number: 24F505154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2024
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2024
• 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