MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE FG, FLOWPORT II ADAPTER, S&N; ACCESSORIES, ARTHROSCOPIC

Catalog Number	CAT00777
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was foreign material.
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.
Additional Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: foreign material.Probable root cause: design: sterilization cycle not capable of reducing bioburden at worst-case locations device design not able to be sterilized sterilization tray design not able to accommodate sterilization of instruments process devices manufactured out of specification such that they represent an increased sterilization challenge application use past expected device life improper cleaning/disinfection before sterilization improper sterilization process, such as use of a cycle not validated for instruments, use of a different tray, or use of other instruments in tray user contaminates device.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text: 81.
Event or Problem Description
It was reported that there was foreign material.

• Brand Name: FG, FLOWPORT II ADAPTER, S&N
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• 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: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 12968491
• Report Number: 0002936485-2021-00696
• Device Sequence Number: 19970816
• Product Code: NBH
• UDI-Device Identifier: 07613252632900
• UDI-Public: 07613252632900
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2022

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: CAT00777
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/10/2021
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 12/09/2021
• Supplement Report FDA Received Date: 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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