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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GEMINI DISLODGER, STONE, BASKET, URETERAL, METAL

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BOSTON SCIENTIFIC CORPORATION GEMINI DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number M0063303060
Device Problems Mechanical Problem (1384); Difficult to Open or Close (2921)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/09/2018
Event Type  malfunction  
Event Description
Surgeon passed the retrieval basket, in the closed position, through the working channel of the ureteroscope to the working end in the kidney. Surgeon was able to deploy the basket to the open position in an attempt to retrieve a stone. Once optimally positioned, the tech was unable to close the basket to capture the specimen. Additional troubleshooting was attempted by the surgeon, but staff was still unable to close the basket. The handle of the device seemed to be locked into the open position and would not move. Surgeon had to damage the device to manually retract the basket. Basket was retracted, removed from the scope/patient and new functional basket was opened.
 
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Brand NameGEMINI
Type of DeviceDISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
780 brookside drive
spencer IN 47460
MDR Report Key7864078
MDR Text Key119815256
Report Number7864078
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM0063303060
Device Catalogue NumberM0063303060
Device Lot Number22275417
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/09/2018
Event Location Hospital
Date Report to Manufacturer09/11/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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