MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPYBITE MAX; FORCEPS, BIOPSY, NON-ELECTRIC

Model Number	M00546470
Medical Device Problem Codes	Difficult to Open or Close (2921); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf f1001 captures the reportable event of aborted/cancelled procedure.
Event or Problem Description
It was reported to boston scientific corporation that a spybite max biopsy forceps was used in the pancreatic duct during a stone crushing / lithotripsy procedure performed on (b)(6) 2024.During the procedure, after crushing the pancreatic stone with electrohydraulic lithotripsy (ehl), resistance was noted in inserting the spybite max into the spy ds ii scope.The forceps was eventually inserted; however, the spy ds ii scope could not display the images.As a result, the jaws could not open to retrieve the stone.Another attempt to retrieve the stone by using the spybite max with the spy ds ii scope was unsuccessful, as the jaws failed to open, making it unusable.Additionally, the working length was kinked.The procedure was aborted as a replacement device was not available.There were no patient complications as result of this event.
Additional Manufacturer Narrative
Block h6: imdrf f1001 captures the reportable event of aborted/cancelled procedure.Block h11: the returned spybite biopsy forceps was analyzed, and a visual inspection observed that the jacket was kinked.The device was observed under magnification, and the jaws were found in good condition.Functional test found the jaws were able to open and close when the handle was actuated.The reported event of jaws failure to open is not confirmed and the reported event "jacket kinked" and "cancelled/rescheduled - post sedation/sedation unknown" are confirmed.Based on all available information, jacket kinked could be caused by procedural or anatomical factors encountered during the use of the device.This issue could affect its performance and its integrity.The damage mentioned could have been generated by insertion/removal of the spybite from/into the scope (hitting a hard surface) or interaction between the spybite and other medical devices.Moreover, the procedure was aborted because there were no more identical or similar devices available.Therefore, the most probable root cause is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a spybite max biopsy forceps was used in the pancreatic duct during a stone crushing / lithotripsy procedure performed on (b)(6) 2024.During the procedure, after crushing the pancreatic stone with electrohydraulic lithotripsy (ehl), resistance was noted in inserting the spybite max into the spy ds ii scope.The forceps was eventually inserted; however, the spy ds ii scope could not display the images.As a result, the jaws could not open to retrieve the stone.Another attempt to retrieve the stone by using the spybite max with the spy ds ii scope was unsuccessful, as the jaws failed to open, making it unusable.Additionally, the working length was kinked.The procedure was aborted as a replacement device was not available.There were no patient complications as result of this event.

• Brand Name: SPYBITE MAX
• Common Device Name: FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19462085
• Report Number: 3005099803-2024-02538
• Device Sequence Number: 20826330
• Product Code: FCL
• UDI-Device Identifier: 08714729996699
• UDI-Public: 08714729996699
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2024

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
• Operator of Device: Health Professional
• Device Model Number: M00546470
• Device Catalogue Number: 4647
• Device Lot Number: 0033039851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2024
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown