MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, PRECISION HD 30°ATS 4.0X140 CMT SLK; ARTHROSCOPE

Catalog Number	0502904030
Medical Device Problem Codes	Crack (1135); Fogging (1253)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
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
Updated e1 initial reporter phone to (b)(6).Updated e1 initial reporter postal code to (b)(6).The product was returned for investigation and the reported failure mode was confirmed.Alleged failure: foggy.Confirmed failure: dented/bent/broken shaft.Rusting.Uneven illumination/dark resolution.Particles in system (in focus).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 failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that there was foggy image.

• Brand Name: PKG, PRECISION HD 30°ATS 4.0X140 CMT SLK
• 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: 21710118
• Report Number: 0002936485-2025-00247
• Device Sequence Number: 15940697
• Product Code: HRX
• UDI-Device Identifier: 07613327063844
• UDI-Public: 07613327063844
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K093677
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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: 0502904030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 06/11/2025
• 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