MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PRECISION IDEAL EYE 5.5 30° HD ACL LAP30; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	0502503030
Medical Device Problem Codes	Fogging (1253); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
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 during surgery.The procedure was completed successfully.
Additional Manufacturer Narrative
The device was not received for investigation at stryker endoscopy because it was repaired locally in stryker india.Problem description (symptom): clarity issue.Action taken at site.(diagnosis): checked and found there is no issue with scope, cleaned with thermal paste and clarity is fine.Final report: scope is working fine only.Job completed: yes.Recommendations to customer: n/a.Probable root cause: laser welding seal failure, distal/proximal window solder failure, damage to optical train, damage to needle, damage to distal or proximal windows, moisture intrusion, end of life wear-out, environmental disturbance: endoscope colder than dew point, environmental disturbance: fluid entrapment between the coupler and eyepiece junction ,(eyepiece only), use error.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that there was foggy image during surgery.The procedure was completed successfully.

• Brand Name: PRECISION IDEAL EYE 5.5 30° HD ACL LAP30
• 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: andy dobos ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 22854880
• Report Number: 0002936485-2025-00707
• Device Sequence Number: 4488612
• Product Code: GCJ
• UDI-Device Identifier: 07613327059144
• UDI-Public: 07613327059144
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K910132
• 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): 10/31/2025

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: 0502503030
• 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: 07/23/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 10/31/2025
• 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