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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE UNKNOWN_ENDOSCOPY_PRODUCT ARTHROSCOPE

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STRYKER ENDOSCOPY-SAN JOSE UNKNOWN_ENDOSCOPY_PRODUCT ARTHROSCOPE Back to Search Results
Catalog Number UNK_END
Device Problems Defective Device (2588); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/05/2019
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. Since the part number has not been provided, the gtin and 510k number are not available at this time. If the part number becomes available, it will be provided in future reports.
 
Event Description
It was reported that the device scuffed the hyaline cartilage.
 
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Brand NameUNKNOWN_ENDOSCOPY_PRODUCT
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 Key9147890
MDR Text Key166833850
Report Number0002936485-2019-00443
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
UNKNOWN
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 12/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK_END
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/05/2019
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

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