MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE AIM 4K COUPLER 20MM C-MOUNT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	1688020122
Medical Device Problem Code	Fogging (1253)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was foggy image.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that there was foggy image.
Additional Manufacturer Narrative
The device was received at the local service facility for investigation.The technical service report indicates: device serial number : (b)(6) already inspected in in house service centre and please find the below remarks of in house engg.Problem description (symptom): foggy issue action taken at site (diagnosis): on inspection found foggy vision coming on monitor, coupler is having moisture inside the lenses.Lenses are not salable.Final report: coupler is being non-serviceable, need to proceed with warranty replacement.Warranty replacement.Job completed: 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 ¿ use error the reported failure mode will be monitored for future reoccurrence.

• Brand Name: AIM 4K COUPLER 20MM 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: 21162270
• Report Number: 0002936485-2025-00038
• Device Sequence Number: 15782917
• Product Code: GCJ
• UDI-Device Identifier: 07613327382389
• UDI-Public: 07613327382389
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 03/21/2025

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: 1688020122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2023
• 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