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

Model Number D2201

Device Problem Material Fragmentation (1261)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/29/2020

Event Type  malfunction  

Event Description

It was reported that this patient underwent a convective radiofrequency water vapor thermal therapy procedure. During the procedure, the device was confirmed to be in good condition and operating appropriately. There were no reported complications reported or clinical consequences to the patient. Three months post procedure, the patient saw his physician and noted that he passed a small fragment in his urine stream approximately between october 19 to october 23; the exact date is unknown. It is unknown if the patient was still using a catheter when the fragment was passed. The fragment was retrieved and will be returned for analysis.

• 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 sceintific way; marlborough MA 01752
• Manufacturer Contact: alyson harris ; 150 baytech drive; san jose, CA 95134 ; 4089353452
• MDR Report Key: 10832984
• MDR Text Key: 219369098
• Report Number: 2937094-2020-00972
• 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,user faci

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: D2201
• Device Catalogue Number: D2201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial