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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE FLOWPORT II CANNULA WITH OBTURATOR STRYKER 165MM; ACCESSORIES, ARTHROSCOPIC

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STRYKER ENDOSCOPY-SAN JOSE FLOWPORT II CANNULA WITH OBTURATOR STRYKER 165MM; ACCESSORIES, ARTHROSCOPIC Back to Search Results
Catalog Number CAT02438
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code Foreign Body In Patient (2687)
Date of Event 01/20/2026
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 a patient had surgery on (b)(6) 2026 using stryker products.On (b)(6) 2026, the doctor removed a disposable piece of flowport cannula from the same patient that had broken off and was left lodged in the patient¿s hip.Revision surgery was required.
 
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Brand Name
FLOWPORT II CANNULA WITH OBTURATOR STRYKER 165MM
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
arsalan rizvi
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key24631496
Report Number0002936485-2026-00160
Device Sequence Number21072364
Product Code NBH
UDI-Device Identifier07613252633181
UDI-Public07613252633181
Combination Product (Y/N)N
Initial Reporter StateMO
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
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) 06/04/2026
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue NumberCAT02438
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Type of Report(Section G)Follow-Up
Initial Date Received by Manufacturer 02/17/2026
Supplement Date Received by Manufacturer05/18/2026
Initial Report FDA Received Date03/18/2026
Supplement Report FDA Received Date06/04/2026
Was Device Evaluated by Manufacturer? (Y/N) No
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)
No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient SexUnknown
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