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 Fever (1858); Urinary Tract Infection (2120); Dysuria (2684)

Event Date 08/17/2018

Event Type  Injury  

Manufacturer Narrative

The device is not available for analysis.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 currently available, the reported patient symptoms are known risk associated with use of the device.An evaluation conclusion code of known inherent risk of the device was assigned to this investigation.

Event Description

It was reported that 8 days post convective radiofrequency water vapor thermal therapy procedure, the patient experienced fever and dysuria.The patient was treated with medication (unknown type and dose) in response to the symptoms.The patient fever was reported to have resolved 12 days post the onset symptom, and the symptom of dysuria resolved 57 days post onset symptom.The patient symptom of dysuria and fever were assessed to be definite treatment related and unlikely related to the device.

Manufacturer Narrative

Describe event or problem: updated to reflect additional patient symptom of uti.The device is not available for analysis.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 currently available, the reported patient symptoms are known risk associated with use of the device.An evaluation conclusion code of known inherent risk of the device was assigned to this investigation.

Event Description

It was reported that 8 days post convective radiofrequency water vapor thermal therapy procedure, the patient experienced fever and dysuria.The patient was treated with medication (unknown type and dose) due to the symptoms.At 9 days the patient was reported to be experiencing a urinary tract infection (uti).The patient was hospitalized due to the severe uti and treated with piperacillin-tazabactam, iv fluids, and levofloxac (dose unknow).The patient fever resolved 12 days post the onset symptom, the dysuria resolved 57 days post onset symptom and the uti resolved 87 days post onset symptom.The patient symptom of dysuria and fever were assessed to be definite treatment related and unlikely related to the device.The uti was assessed as probable procedure related and not related to the device.The clinical end point committee adjudicated the uti as definitely related to treatment and unlikely related to the device.No further information was provided.

• 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
• MDR Report Key: 8824641
• MDR Text Key: 152162526
• Report Number: 2937094-2019-60911
• 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: study,user facility
• Type of Report: Initial,Followup
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Device Lot Number: 2018020319
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/27/2019
• Initial Date FDA Received: 07/24/2019
• Supplement Dates Manufacturer Received: 03/12/2020
• Supplement Dates FDA Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 63 YR