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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE SLINGSHOT 45 DEG UP; PASSER
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STRYKER ENDOSCOPY-SAN JOSE SLINGSHOT 45 DEG UP; PASSER Back to Search Results
Catalog Number CAT02589
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/21/2023
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 the jaw of the device broke during the procedure.The piece was retrieved.
 
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Brand Name
SLINGSHOT 45 DEG UP
Type of Device
PASSER
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
lucas wolski
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key18499680
MDR Text Key332995239
Report Number0002936485-2024-00041
Device Sequence Number1
Product Code HWQ
UDI-Device Identifier07613252656609
UDI-Public07613252656609
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 Other
Type of Report Initial
Report Date 01/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCAT02589
Device Lot Number009623
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/21/2023
Initial Date FDA Received01/11/2024
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
Patient Sequence Number1
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