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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE CROSSFLOW INFLOW CASSETTE TUBING; ARTHROSCOPE
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STRYKER ENDOSCOPY-SAN JOSE CROSSFLOW INFLOW CASSETTE TUBING; ARTHROSCOPE Back to Search Results
Catalog Number 0450000100
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/20/2023
Event Type  malfunction  
Event Description
It was reported that foreign material was found inside the sterile packaging.
 
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.
 
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Brand Name
CROSSFLOW INFLOW CASSETTE TUBING
Type of Device
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
lucas wolski
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key18341170
MDR Text Key330987487
Report Number0002936485-2023-01268
Device Sequence Number1
Product Code HRX
UDI-Device Identifier37613327055208
UDI-Public37613327055208
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123441
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/15/2023
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 Other
Device Catalogue Number0450000100
Device Lot NumberK23D077
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 11/21/2023
Initial Date FDA Received12/15/2023
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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