MAUDE Adverse Event Report: MEDPLAST MEDICAL, INC. REZUM; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number D2201

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

Patient Problems Hematuria (2558); Dysuria (2684); Constipation (3274)

Event Date 01/06/2020

Event Type  Injury  

Manufacturer Narrative

The device is not available for analysis.The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.A review of the device ifu and operators manual was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.The potential cause and controls for complaints related to clinical events were identified.Based on the information available, an evaluation conclusion code of known inherent risk of the device was assigned to this investigation.

Event Description

It was reported that the patient underwent convective radiofrequency water vapor thermal therapy procedure of the prostate.During the procedure the patient was given prostate block or epidural, anxiety medication and pain medication.A total of 9 treatments were delivered.There were no device observations or adverse event during procedure.The patient was reported to be giving throughout treatment valium 10m, oxycodone, acetaminophen 5/325mg, pyridium 200mg, bactrim 160/800mg.It was reported that 4 days post procedure the patient experienced constipation, hematuria/pericatheter bleeding and pain with urination.The patient was given prune juice for the constipation.There was no treatment administered for the patient symptoms of hematuria/pericatheter bleeding and pain with urination.The hematuria/pericatheter bleeding and pain with urination symptoms resolved 4 days post onset symptoms.The constipation symptom resolved 10 post onset symptom.The patient symptoms were reported to be probable related to procedure and unlikely related to the device.

• Brand Name: REZUM
• Type of Device: UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): MEDPLAST MEDICAL, INC.; 5079 33rd street se; grand rapids MI 49512
• Manufacturer (Section G): MEDPLAST MEDICAL, INC.; 5079 33rd street se; grand rapids MI 49512
• Manufacturer Contact: alyson harris ; 150 baytech drive; san jose, CA 95134 ; 4089353452
• MDR Report Key: 9772646
• MDR Text Key: 181565426
• Report Number: 2937094-2020-00204
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: D2201
• Device Catalogue Number: D2201
• Device Lot Number: 2019041262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2019
• 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
• Patient Age: 73 YR