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

Model Number	M0063901050
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a zero tip was used during a ureteroscopy laser lithotripsy procedure.Prior to procedure, a black specs were found floating in the package.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a1802 captures the reportable event of device contaminated during manufacture or shipping.
Additional Manufacturer Narrative
Block h6: imdrf device code a1802 captures the reportable event of device contaminated during manufacture or shipping.Correction to block e3: occupation block h11: the device was not returned for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information provided, the most probable cause of the reported issue cannot be established due to lack of evidence.Additionally, without a proper evaluation of the device or objective evidence, it remains unknown the most probable causes that could have contributed to the event.A risk review was completed and confirmed that the event of "packaging foreign matter" was defined in the risk documentation and is documented accordingly in the prr.This event type has been accounted during product risk analysis to support acceptable risk benefits for the product.Therefore, this complaint is assigned an investigation conclusion code of "unable to exclude device problem" since the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.
Event or Problem Description
It was reported that a zero tip was used during a ureteroscopy laser lithotripsy procedure.Prior to procedure, a black specs were found floating in the package.The procedure was completed with another of the same device.There were no patient complications as a result of this event.

• Brand Name: ZERO TIP
• Common Device Name: DISLODGER, STONE, BASKET, URETERAL, METAL
• 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: 24568785
• Report Number: 2124215-2026-13250
• Device Sequence Number: 20924418
• Product Code: FFL
• UDI-Device Identifier: 08714729469643
• UDI-Public: (01)08714729469643
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K924608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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: M0063901050
• Device Catalogue Number: M0063901050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 04/10/2026
• 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