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 Problem Incontinence (1928)

Event Date 09/01/2019

Event Type  Injury  

Manufacturer Narrative

This report is for the same patient procedure as manufacturer report: 2937094-2019-61241.

Event Description

The patient underwent convective radiofrequency water vapor thermal therapy procedure.The patient was given iv sedation, pain medication, and general anesthesia.During procedure, a total of 12 treatments were delivered.There were no device observations or adverse events during the procedure.The subject was discharged with an indwelling catheter and removed seven days post procedure.It was reported that at 35 days post the index procedure, the patient is experiencing intermittent worsening urge incontinence that is still ongoing.No treatment has been administered in response to the patient symptom.The facility investigator assessed the worsening urge incontinence patient symptom as possible related to the procedure and device.

Event Description

The patient underwent convective radiofrequency water vapor thermal therapy procedure.The patient was given iv sedation, pain medication, and general anesthesia.During procedure, a total of 12 treatments were delivered.There were no device observations or adverse events during the procedure.The subject was discharged with an indwelling catheter and removed seven days post procedure.It was reported that at 35 days post the index procedure, the patient is experiencing intermittent worsening urge incontinence that is still ongoing.No treatment has been administered in response to the patient symptom.The facility investigator assessed the worsening urge incontinence patient symptom as possible related to the procedure and device.

Manufacturer Narrative

This report is for the same patient procedure as manufacturer report: 2937094-2019-61241.The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.The device is not available for analysis.The potential cause and controls for complaints related to clinical events were identified.Based on the information currently available, the patient symptom is 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

The patient underwent convective radiofrequency water vapor thermal therapy procedure.The patient was given iv sedation, pain medication, and general anesthesia.During procedure, a total of 12 treatments were delivered.There were no device observations or adverse events during the procedure.The subject was discharged with an indwelling catheter and removed seven days post procedure.It was reported that at 35 days post the index procedure, the patient is experiencing intermittent worsening urge incontinence.No treatment was administered and the symptom was reported to have resolved 153 days post onset symptom.The facility investigator assessed the worsening urge incontinence patient symptom as possible related to the procedure and device.

Manufacturer Narrative

B5 event description: updated to reflect resolution of worsening of incontinence.This report is for the same patient procedure as manufacturer report: 2937094-2019-61241.The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.The device is not available for analysis.The potential cause and controls for complaints related to clinical events were identified.Based on the information currently available, the patient symptom is known risk associated with this type of procedure.An evaluation conclusion code of known inherent risk of the device was assigned to this investigation.

• 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: 9319160
• MDR Text Key: 166624674
• Report Number: 2937094-2019-61532
• 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,Followup
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: D2201
• Device Catalogue Number: D2201
• Device Lot Number: 2018110702
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR