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 Muscle Spasm(s) (1966); Discomfort (2330); Patient Problem/Medical Problem (2688)

Event Date 09/14/2018

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 patient symptoms are known risk associated with this type of procedure.An evaluation conclusion code of known inherent risk of the device was assigned to this investigation.

Event Description

It was reported that two days post convective radiofrequency water vapor thermal therapy procedure, the patient experienced bladder spasms and sore penis.The patient was treated (unknown treatment type) for the bladder spasms symptom.At 8 days post procedure, the patient experienced post voiding dribbling for which treatment (unknown treatment type) was administered.The patient symptom of bladder spasm was reported to have resolved 6 six post onset symptom, the sore penis symptom resolved 25 days post onset symptom without treatment, and the symptom of post voiding dribbling resolved 43 days post onset symptom.The patient symptom of bladder spasms was assessed as probable treatment related and unlikely related to the device.The patient symptom of sore penis was assessed as probable treatment and device related.The symptom of post voiding dribbling was assessed as definite treatment related 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: 8832257
• MDR Text Key: 152371074
• Report Number: 2937094-2019-60913
• 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: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• 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
• Device Lot Number: 2018020319
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2019
• 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; Required Intervention
• Patient Age: 69 YR