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

Catalog Number CAT00777

Device Problem Contamination /Decontamination Problem (2895)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2021

Event Type  malfunction  

Event Description

It was reported that there was foreign material.

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.

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 Description

It was reported that there was foreign material.

• Brand Name: FG, FLOWPORT II ADAPTER, S&N
• Type of Device: 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
• MDR Text Key: 283520327
• Report Number: 0002936485-2021-00696
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 07613252632900
• UDI-Public: 07613252632900
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: CAT00777
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 12/09/2021
• Supplement Dates Manufacturer Received: 11/10/2021
• Supplement Dates FDA Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1