MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PRECISION IE 4K EYEPIECE ARTHROSCOPE, AUTOCLAVABLE, 4MM X 70°, 140MM, SPEED-LOCK

Catalog Number	0502444070
Medical Device Problem Codes	Fogging (1253); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2023
Type of Reportable Event	Malfunction
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 there was foggy image.
Event or Problem Description
It was reported that there was foggy image.
Additional Manufacturer Narrative
This scope was not received for evaluation at stryker endoscopy.This scope was received at henke for evaluation.Based on the henke service report, the reported failure "scratched/foggy" was confirmed.According to henke: scope has been evaluated as a level 3 repair due to distal tip dents, fiber damage, internal moisture, particulates, needle dents and scratches.Blurry image on camera system.The complaint can be confirmed.Damage is due to customer use and/or handling.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.

• Brand Name: PRECISION IE 4K EYEPIECE ARTHROSCOPE, AUTOCLAVABLE, 4MM X 70°, 140MM, SPEED-LOCK
• 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: 18374784
• Report Number: 0002936485-2023-01308
• Device Sequence Number: 18070753
• Product Code: HRX
• UDI-Device Identifier: 07613327405910
• UDI-Public: 07613327405910
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K183470
• 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): 06/20/2024

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: 0502444070
• 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: 12/08/2023
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 06/20/2024
• 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