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

Model Number D2201

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Impotence (1925); Patient Problem/Medical Problem (2688)

Event Date 08/01/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: the exact event date is unknown.The device is not available for analysis.A review of the device ifu and operators manual was completed and there is no evidence the device was used contrary to product labeling.Erectile dysfunction and ejaculation are potential adverse event associated with this types of procedures and noted as such in the instructions for use (ifu).Based on the information currently available an evaluation conclusion code of known inherent risk of the device was assigned to this investigation.

Event Description

The patient reported to have undergone convective radiofrequency water vapor thermal therapy procedure of the prostate 19 months ago.The procedure helped with urination, but the patient is experiencing inability to ejaculate and erectile disfunction (ed).No further information is available.

• Brand Name: REZUM
• Type of Device: 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; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: alyson harris ; 150 baytech drive; san jose, CA 95134 ; 4089353452
• MDR Report Key: 10502060
• MDR Text Key: 205924399
• Report Number: 2937094-2020-00797
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• PMA/PMN Number: K180237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D2201
• Device Catalogue Number: D2201
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other