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

Model Number	M0065051600
Medical Device Problem Codes	Difficult to Open or Close (2921); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a051104 captures the reportable event of jaws failed to close.
Event or Problem Description
It was reported that a piranha biopsy forceps was used during a procedure.Reportedly, the cup cannot be open or closed even when the handle was operated.The procedure was completed with another of the same device with no patient complications.
Event or Problem Description
It was reported that a piranha biopsy forceps was used during a procedure.Reportedly, the cup cannot be open or closed even when the handle was operated.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Block h6: device code a051104 captures the reportable event of jaws unable to close.Block h11: investigation results the returned piranha forceps device was analyzed, and a visual evaluation noted that the coil jacket was kinked at the proximal and middle section and the reported event of the jaws unable to open could be related with the damage.Functional examination was performed with the device actuated and it's unable to open.Microscopic examination was performed, and it was noticed that the coil jacket was kinked at the proximal section.With the available information, boston scientific concludes that the device returned with the piranha device has the jacket kinked at the proximal side of the device which can cause difficulty to actuate the handle consequently making the jaws unable to open.Based on analysis results, the reported device performance allegation could be confirmed.The observed issues could be related to operational factors during their use could lead to kink the device making unable for the jaws to perform its function of opening.Taking all available information into consideration, the most probable cause of this complaint is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on the event.

• Brand Name: PIRANHA
• Common Device Name: FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22907434
• Report Number: 2124215-2025-59716
• Device Sequence Number: 8863126
• Product Code: FCL
• UDI-Device Identifier: 08714729302599
• UDI-Public: (01)08714729302599(17)280320(10)36122222
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/13/2025

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: M0065051600
• Device Catalogue Number: M0065051600
• Device Lot Number: 0036122222
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2025
• 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