MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 4MM X 30DEG C-MOUNT ARTHROSCOPE A/C

Catalog Number	0502527030
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacture 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 the image was blurry and new scope was used to complete the procedure.
Event or Problem Description
It was reported the image was blurry and new scope was used to complete the procedure.
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 record attached, the reported failure [blurry] was confirmed.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.According to henke: the cover glass of the distal end is full of deposits, making the image on the camera blurry.(see attached investigation report).Probably root cause for this failure is: ¿ incorrectly assembled optical train ¿ damage to optical train ¿ end of life wear-out ¿ shipping damage ¿ use error.The device manufacture date is not known.

• Brand Name: PKG, 4MM X 30DEG C-MOUNT ARTHROSCOPE A/C
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8696911
• Report Number: 0002936485-2019-00235
• Device Sequence Number: 1942064
• Product Code: HRX
• UDI-Device Identifier: 07613327059298
• UDI-Public: 07613327059298
• Combination Product (Y/N): N
• PMA/510(K) Number: K962075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2019

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: 0502527030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 08/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1