MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SEAL BIOPSY VALVE; ENDOSCOPIC IRRIGATION/SUCTION SYSTEM

Model Number	SBC-501
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a seal biopsy valve was used during a procedure performed on an unknown date.During the procedure, the seal biopsy cap leaked.It was reported that the cap leaked onto personnel in the room but no treatment was needed.The procedure was completed with a non- bsc device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block d4: the complainant was unable to provide the suspect device ot number; therefore, the expiration and device manufacture dates are unknown.Block h6: device code a0504 captures the reportable event of biopsy cap leak.

• Brand Name: SEAL BIOPSY VALVE
• Common Device Name: ENDOSCOPIC IRRIGATION/SUCTION SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): NOLATO CONTOUR INC; nolato contour inc; baldwin WI 54002
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16973656
• Report Number: 3005099803-2023-02695
• Device Sequence Number: 2317804
• Product Code: OCX
• UDI-Device Identifier: 08714729981596
• UDI-Public: 08714729981596
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/22/2023

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: SBC-501
• Device Catalogue Number: 2235-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown