MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DREAMTOME¿ PRO RX 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00584400
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: patient was having a ercp [endoscopic retrograde cholangiopancreatography] with dr [redacted].During the procedure the wire was exposed through the wire covering.Patient wasn't harmed nor damage to the scope.

• 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
• MDR Report Key: 22838133
• Report Number: 22838133
• Device Sequence Number: 9247407
• Product Code: KNS
• UDI-Device Identifier: 00191506039240
• UDI-Public: (01)00191506039240
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/15/2025
• Report Date (Section F): 08/15/2025

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: M00584400
• Device Catalogue Number: M00584400
• Device Lot Number: 36103387
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/19/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 85 KG
• Date Report Sent to FDA: 08/15/2025