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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE CHAMPION SLINGSHOT 45 RIGHT PASSER

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STRYKER ENDOSCOPY-SAN JOSE CHAMPION SLINGSHOT 45 RIGHT PASSER Back to Search Results
Model Number CAT02855
Device Problem Expiration Date Error (2528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/14/2020
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 an expired product was used in a procedure.
 
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Brand NameCHAMPION SLINGSHOT 45 RIGHT
Type of DevicePASSER
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 Key10105121
MDR Text Key193940629
Report Number0002936485-2020-00214
Device Sequence Number1
Product Code HWQ
Combination Product (y/n)N
Reporter Country CodeAU
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 08/04/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCAT02855
Device Catalogue NumberCAT02855
Device Lot Number003180
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 Received05/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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