MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PRECISION IDEAL EYES 10MM 30° HD AC LPSC; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	0502103030
Medical Device Problem Code	Fogging (1253)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
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 the optics gave unclear, foggy picture on the screen.
Additional Manufacturer Narrative
This event was initially reported as a malfunction for foggy image.Upon additional information provided, this event is no longer reportable.Addtional information received confirmed that there was no associated procedure associated with this complaint.This event description most likely indicates ¿foggy image¿.The review of historical complaint data, risk documentation, and the reported information regarding this event do not suggest a recurrence of this event would be likely to result in a serious injury.No adverse consequences were determined to be reportable.This event is no longer determined to be reportable.
Event or Problem Description
This event was initially reported as a malfunction for foggy image.Upon additional information provided, this event is no longer reportable.Addtional information received confirmed that there was no associated procedure associated with this complaint.This event description most likely indicates ¿foggy image¿.The review of historical complaint data, risk documentation, and the reported information regarding this event do not suggest a recurrence of this event would be likely to result in a serious injury.No adverse consequences were determined to be reportable.This event is no longer determined to be reportable.

• Brand Name: PRECISION IDEAL EYES 10MM 30° HD AC LPSC
• 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: 23782501
• Report Number: 0002936485-2025-00980
• Device Sequence Number: 12019343
• Product Code: GCJ
• UDI-Device Identifier: 07613327062182
• UDI-Public: 07613327062182
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K910132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

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: 0502103030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 12/23/2025
• 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