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

Catalog Number	1688410105
Medical Device Problem Code	Fogging (1253)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/30/2025
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 foggy image.
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: foggy image.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.
Event or Problem Description
It was reported that there was foggy image.
Additional Manufacturer Narrative
Updating reportability awareness date based on fda acknowledgement of stryker endoscopy's decision to cease reporting for foggy images on endoscopic camera systems and devices.
Event or Problem Description
It was reported that there was foggy image.
Additional Manufacturer Narrative
Please note we are discontinuing the current practice of filing malfunction medical device reports (mdrs) for reported complaints related to foggy images on stryker endoscopy's endoscopic camera systems and devices.The camera systems are an endoscopic camera system that is used to produce live video in the surgical field during endoscopic surgical procedures.The system is sensitive in the visible and infrared spectrum.The optical image is transferred from the surgical site to the camera head by a variety of rigid and flexible scopes, which are attached to the camera head.The system consists of a camera console and a camera head with an integral cable that connects to the console.A coupler is also available for attaching a scope to the camera head.This malfunction has not caused or contributed to any deaths or serious injuries in the last two years.Based on the information provided, it has been determined that this malfunction is unlikely to cause or contribute to death or serious injury should the malfunction recur.Therefore, we intend to discontinue filing mdrs for foggy images on stryker endoscopy's endoscopic camera systems and devices.
Event or Problem Description
It was reported that there was foggy image.

• Brand Name: PKG 1688 AIM 4K AUTOCLAVABLE 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: 21453453
• Report Number: 0002936485-2025-00139
• Device Sequence Number: 17964529
• Product Code: GCJ
• UDI-Device Identifier: 07613327562545
• UDI-Public: 07613327562545
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K212511
• 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,Followup
• Report Date (Section B): 05/29/2025

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: 1688410105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 03/31/2025; 03/31/2025; 05/07/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 04/28/2025; 05/29/2025; 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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