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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PRECISION IE 4K C-MOUNT ARTHROSCOPE, AUTOCLAVABLE, 4MM X 30°, 140MM, SPEED-LOCK
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STRYKER ENDOSCOPY-SAN JOSE PRECISION IE 4K C-MOUNT ARTHROSCOPE, AUTOCLAVABLE, 4MM X 30°, 140MM, SPEED-LOCK Back to Search Results
Model Number 0502-404-030
Device Problems Optical Problem (3001); Insufficient Information (3190)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/15/2021
Event Type  Injury  
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 procedure was converted to open.
 
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Brand NamePRECISION IE 4K C-MOUNT ARTHROSCOPE, AUTOCLAVABLE, 4MM X 30°, 140MM, SPEED-LOCK
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
chester rebugio
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key12733735
MDR Text Key279526267
Report Number0002936485-2021-00590
Device Sequence Number1
Product Code HRX
UDI-Device Identifier07613327416497
UDI-Public07613327416497
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K183470
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0502-404-030
Device Catalogue Number0502404030
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/15/2021
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 Treatment Data
Date Received: 11/01/2021 Patient Sequence Number: 1
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