MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE HD 4MM X 30° 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	09/23/2021
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 blurry image.
Additional Manufacturer Narrative
The device manufacturer date is not known.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 "image not clear" was confirmed.According to henke: scope evaluated as a level 3.Distal tip/fiber damage, bent needle, dents in needle, damaged sidearm lens, broken lenses, chipped/scratched negative, distal moisture, scratches on needle, residue on external optics and paint missing in engraving.Probably root cause for this failure is: the complaint for ¿image not clear during use¿ has been confirmed and damage is due to customer use and handling.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that there was blurry image.

• Brand Name: HD 4MM X 30° ARTHROSCOPE, SPEEDLOCK, C-MOUNT, 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: 12677875
• Report Number: 0002936485-2021-00555
• Device Sequence Number: 14628531
• Product Code: HRX
• UDI-Device Identifier: 07613327062755
• UDI-Public: 07613327062755
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 12/07/2021

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: Health Professional
• Device Model Number: 0502704030
• Device Catalogue Number: 0502704030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/23/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 12/07/2021
• 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