MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 1688 AIM 4K COUPLER KIT - INTERNATIONAL KIT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	1688020122I
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
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
Additional information: d4 gtin is (b)(4).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 image quality.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 (sensor, sensor cable), coupler (dust on optics, scratched optics, broken / shifted lenses, focusing mechanism, endoclamp, zoom ring), problem toggling light source, connected monitors, leaking, poor grounding (e.G camera head connection from cable to transition board.), 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, or use error.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that there was poor image quality.
Event or Problem Description
It was reported that there was poor image quality.
Additional Manufacturer Narrative
Alleged failure: the backlight issue with the camera head prevents white balance adjustment and degrades image quality.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.Root cause: no problem found.The cause of the issue could be the ccu, the scope, or other equipment used along with the coupler.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• Brand Name: 1688 AIM 4K COUPLER KIT - INTERNATIONAL KIT
• 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: arsalan rizvi ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 21061228
• Report Number: 0002936485-2025-00008
• Device Sequence Number: 8067792
• Product Code: GCJ
• UDI-Device Identifier: 07613327382389
• UDI-Public: 07613327382389
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Followup
• Report Date (Section B): 03/18/2026

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: 1688020122I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 03/12/2025; 02/28/2026
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 04/09/2025; 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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