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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION GRASPIT DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number M0063204010
Device Problems Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Patient Problem Insufficient Information (4580)
Event Date 12/06/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). According to the complainant, the suspect device has been disposed and is not available for return. If any further relevant information is received, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that a graspit nitinol stone retrieval forceps was used in the ureter during a flexible ureterorenoscopy procedure performed on (b)(6) 2020. During the procedure, the forceps of the graspit broke off inside the flexible ureteroscope. Additionally, the sheath at the distal end snapped off. Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts. No patient complications were reported as a result of this event.
 
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Brand NameGRASPIT
Type of DeviceDISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
780 brookside drive
spencer IN 47460
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key11398697
MDR Text Key234301776
Report Number3005099803-2021-00769
Device Sequence Number1
Product Code FFL
UDI-Device Identifier08714729341758
UDI-Public08714729341758
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 03/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM0063204010
Device Catalogue Number320-401
Device Lot Number0025820220
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/06/2020
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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