MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, PRECISION HD 30 DEG., ARTHROSCOPE, 2.3MM X 72MM, C-MOUNT, SPEEDLOCK, A/C

Catalog Number	0502822030
Medical Device Problem Codes	Poor Quality Image (1408); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was dark image during the procedure.
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.
Additional Manufacturer Narrative
The product was returned for investigation and the reported failure mode was confirmed.Alleged failure: dark image.Confirmed failure: outer tube damaged (bent, dented).Broken rod lens.Loose optical system.Probable root cause: incorrect or unclear instructions for use; incorrect optics assembly; incorrect scope adapter assembly; light cone failure; damaged light fibers; incorrectly assembled fibers; end of life wear-out; shipping damage; use error; insufficient amount of fibers; insufficient illumination uniformity.Manufacture date is not known.The failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that there was dark image during the procedure.

• Brand Name: PKG, PRECISION HD 30 DEG., ARTHROSCOPE, 2.3MM X 72MM, C-MOUNT, SPEEDLOCK, A/C
• 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: 17687219
• Report Number: 0002936485-2023-00890
• Device Sequence Number: 6512706
• Product Code: HRX
• UDI-Device Identifier: 07613327060089
• UDI-Public: 07613327060089
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K093677
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2024

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: 0502822030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 07/01/2024
• 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