MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Dreamtome Pro RX 44; Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Model Number	M00584400
Medical Device Problem Codes	Use of Device Problem (1670); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2026
Type of Reportable Event	Malfunction

• Brand Name: Dreamtome Pro RX 44
• Common Device Name: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 50695465
• Report Number: 3005099803-2026-03673
• Device Sequence Number: 5975699
• Product Code: KNS
• UDI-Device Identifier: 00191506039240
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K232162
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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: M00584400
• Device Catalogue Number: M00584400
• Device Lot Number: 0038709116
• 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: 08/17/2026
• Initial Report FDA Received Date: 09/09/2026
• Date Device Manufactured: 02/27/2026
• 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