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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE CLARITY CONSOLE SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

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STRYKER ENDOSCOPY-SAN JOSE CLARITY CONSOLE SYSTEM, IMAGE PROCESSING, RADIOLOGICAL Back to Search Results
Catalog Number 0240260000
Device Problem Poor Quality Image (1408)
Patient Problem No Code Available (3191)
Event Date 12/17/2018
Event Type  Injury  
Manufacturer Narrative
The device manufacture date is not known at this time. However, should it become available it will be provided in future reports. Additional information will be provided once the investigation has been completed.
 
Event Description
It was reported that the image became grainy and had to convert to open surgery.
 
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Brand NameCLARITY CONSOLE
Type of DeviceSYSTEM, IMAGE PROCESSING, RADIOLOGICAL
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
michelle to
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key8224686
MDR Text Key132375573
Report Number0002936485-2019-00009
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130929
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 04/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0240260000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/17/2018
Was Device Evaluated by Manufacturer? Yes
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: 01/07/2019 Patient Sequence Number: 1
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