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 Problem Inflammation (1932)

Event Date 11/04/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: the exact date of the event was not reported.

Event Description

It was reported that the physician has a patient that had severe left sided colitis inflammation in colon.The patient had received water vapor thermal therapy shortly before the patients symptoms occurred.The physician suspected that this is due to the device.

• Brand Name: REZUM
• Type of Device: UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752 1242
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: alyson harris ; 150 baytech drive; san jose, CA 95134 ; 4089353452
• MDR Report Key: 9324892
• MDR Text Key: 181981925
• Report Number: 3001236349-2019-00002
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191505
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2019
• 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