MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 4MM 30° C-MOUNT STYLE A ARTHROSCOPE

Model Number	0502427030
Medical Device Problem Codes	Poor Quality Image (1408); Optical Problem (3001)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/11/2020
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 a poor image during procedure.
Additional Manufacturer Narrative
The product was returned for investigation and the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.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 [bad image] was not confirmed.According to henke: scope has been evaluated as a level 3 repair due to the distal tip and fiber damage, dent and scratches along the needle.Cannot confirm the complaint (image is bad) probably root cause for this failure is:damage is due to customer use and/or handling.Manufacture date is not known.
Event or Problem Description
It was reported that there was a poor image during procedure.

• Brand Name: PKG, 4MM 30° C-MOUNT STYLE A ARTHROSCOPE
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9930934
• Report Number: 0002936485-2020-00157
• Device Sequence Number: 16848486
• Product Code: HRX
• UDI-Device Identifier: 07613327059113
• UDI-Public: 07613327059113
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2020

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: 0502427030
• Device Catalogue Number: 0502427030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2020
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 05/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1