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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, CROSSFLOW CONSOLE ARTHROSCOPE

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STRYKER ENDOSCOPY-SAN JOSE PKG, CROSSFLOW CONSOLE ARTHROSCOPE Back to Search Results
Model Number 0450000000
Device Problems Insufficient Flow or Under Infusion (2182); Pressure Problem (3012)
Patient Problems Swelling/ Edema (4577); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/30/2021
Event Type  malfunction  
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 Description
It was reported that the patient was swelling more than usual after the procedure. Note, although swelling occurred, there is no indication of extravasation or serious injury as a result of the swelling.
 
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Brand NamePKG, CROSSFLOW CONSOLE
Type of DeviceARTHROSCOPE
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 Key12543507
MDR Text Key274501488
Report Number0002936485-2021-00516
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
K123441
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0450000000
Device Catalogue Number0450000000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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