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

Model Number	0502704030
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2021
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
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 [foggy] was confirmed.According to henke: scope evaluated as a level 3.Severe tip and fiber damage, scratched on distal lens negative and moisture in system.Probably root cause for this failure is: customer use and handling.The failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
It was reported that there was foggy image.

• Brand Name: HD 4MM X 30A ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 11894981
• Report Number: 0002936485-2021-00280
• Device Sequence Number: 19689490
• Product Code: HRX
• UDI-Device Identifier: 07613327062755
• UDI-Public: 07613327062755
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K093677
• 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): 07/16/2021

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: Other
• Device Model Number: 0502704030
• Device Catalogue Number: 0502704030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 07/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1