MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PRECISION IE 4K EYPC ATSC AUCL4X70°165SL; ARTHROSCOPE

Catalog Number	0502445070
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that a hip arthroscopy was scheduled for that day.During the operation, the new 70° optic became blurred and therefore unusable, so the surgeon decided to try and continue with a 30° optic, which was not at all suitable for the operation, so the patient's hip had to be opened to continue and finalize the operation.
Additional Manufacturer Narrative
Three attempts have been made to retrieve the device for evaluation.The device has not been received in-house.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: blurry probable root cause: incorrectly assembled optical train.Damage to optical train.End of life wear-out.Shipping damage.Use error.The reported failure mode will be monitored for future reoccurrence.The manufacture date is not known.
Event or Problem Description
It was reported that a hip arthroscopy was scheduled for that day.During the operation, the new 70° optic became blurred and therefore unusable, so the surgeon decided to try and continue with a 30° optic, which was not at all suitable for the operation, so the patient's hip had to be opened to continue and finalize the operation.

• Brand Name: PRECISION IE 4K EYPC ATSC AUCL4X70°165SL
• Common Device Name: ARTHROSCOPE
• 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: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 21890931
• Report Number: 0002936485-2025-00376
• Device Sequence Number: 8126539
• Product Code: HRX
• UDI-Device Identifier: 07613327405941
• UDI-Public: 07613327405941
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K183470
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0502445070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 07/07/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown