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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PIVOT GUARDIAN, FRAME APPARATUS, TRACTION, NON-POWERED

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STRYKER ENDOSCOPY-SAN JOSE PIVOT GUARDIAN, FRAME APPARATUS, TRACTION, NON-POWERED Back to Search Results
Model Number 3105000100
Device Problem Material Fragmentation (1261)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/21/2022
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 sales representative got slivers of the device in their finger while wiping it down which required intervention to remove.
 
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Brand NamePIVOT GUARDIAN, FRAME
Type of DeviceAPPARATUS, TRACTION, NON-POWERED
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 Key14879258
MDR Text Key295115559
Report Number0002936485-2022-00405
Device Sequence Number1
Product Code HST
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
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 06/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3105000100
Device Catalogue Number3105000100
Was Device Available for Evaluation? Yes
Date Manufacturer Received06/22/2022
Was Device Evaluated by Manufacturer? No
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: 06/30/2022 Patient Sequence Number: 1
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