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

Model Number	M0063204010
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/06/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.

• Brand Name: GRASPIT
• Common Device Name: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11398697
• Report Number: 3005099803-2021-00769
• Device Sequence Number: 14298249
• Product Code: FFL
• UDI-Device Identifier: 08714729341758
• UDI-Public: 08714729341758
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/06/2023
• Device Model Number: M0063204010
• Device Catalogue Number: 320-401
• Device Lot Number: 0025820220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 03/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1