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

Model Number	M00583040
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a hydratome rx 44 was received by the customer on an unknown date.It was reported that there are holes in the packaging.A photo of the sterile pouch of the device was provided and showed that the sterile pouch was torn.The product was not used in a procedure.No further information has been obtained despite good faith efforts.There were no patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a020504 captures the reportable event of a tear, rip, or hole in the device packaging.
Additional Manufacturer Narrative
B3: approximated based on the date the manufacturer became aware of the event.H6: imdrf device code a020504 captures the reportable event of a tear, rip, or hole in the device packaging.H11: investigation results: the hydratome rx 44 device was not returned as it was reported to be disposed.A technical analysis could not be performed.However, a media analysis was performed on the two photos provided by the complainant where it can be observed that the device with its wire inside the labeled pouch, the pouch presents some black dots, however, it was not possible to determine if these dots are actually holes, another photo was provided and shows that the pouch was torn.No other problems with the device were noted.According to the photo provided by the customer the reported event of packaging tear, rip or hole in device packaging was confirmed.The results of the media analysis performed observed that the pouch was torn, however, the most probable cause of the reported event cannot be established due to lack of evidence.The product was not returned for analysis as it was reported to be disposed, and a technical analysis could not be performed.The investigation concluded that, without analysis of the device, the most probable root cause of the clinical observations is cause not established.
Event or Problem Description
It was reported to boston scientific corporation that a hydratome rx 44 was received by the customer on an unknown date.It was reported that there are holes in the packaging.A photo of the sterile pouch of the device was provided and showed that the sterile pouch was torn.The product was not used in a procedure.No further information has been obtained despite good faith efforts.There were no patient complications have been reported as a result of this event.

• Brand Name: HYDRATOME 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22503776
• Report Number: 3005099803-2025-03325
• Device Sequence Number: 21143930
• Product Code: KNS
• UDI-Device Identifier: 08714729755197
• UDI-Public: (01)08714729755197(17)280330(10)36195590
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K013153
• 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): 08/28/2025

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: M00583040
• Device Catalogue Number: M00583040
• Device Lot Number: 0036195590
• 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: 06/24/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 08/28/2025
• Date Device Manufactured: 03/31/2025
• 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