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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 Problems Mechanical Problem (1384); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/11/2020
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 there was a loss of traction during the procedure.
 
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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 Key11132323
MDR Text Key226999510
Report Number0002936485-2021-00006
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
Type of Report Initial,Followup
Report Date 03/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3105000100
Device Catalogue Number3105000100
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2020
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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