MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PRECISION IE 4K CMT ASC ATCL4X70° 165SLK; ARTHROSCOPE

Catalog Number	0502414070
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that their scope was blurry on the first use.
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.
Additional Manufacturer Narrative
The device was not returned for evaluation.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.
Event or Problem Description
It was reported that there scope was blurry on the first use.

• Brand Name: PRECISION IE 4K CMT ASC ATCL4X70° 165SLK
• 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: arsalan rizvi ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 23911077
• Report Number: 0002936485-2025-01023
• Device Sequence Number: 15740319
• Product Code: HRX
• UDI-Device Identifier: 07613327416435
• UDI-Public: 07613327416435
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2026

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: 0502414070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/22/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 01/07/2026
• 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