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); Urinary Retention (2119)

Event Date 07/17/2019

Event Type  Injury  

Event Description

The patient underwent the study procedure and was given a prostate block, epidural, anti-anxiety and pain medication.During procedure a total of 15 treatments were performed.No device observations or adverse events occurred during treatment.The same day post procedure, the patient experienced bladder spasms for which myrbetriq (dose unknown) was administered.The bladder spasm resolved 7 days post onset symptoms.At 7 days post the index procedure, the patient started experiencing urinary retention for which catherization was performed.The urinary retention resolved 20 days post onset symptom.The investigator assessment of the patient symptom of bladder spasms and urinary retention were assessed as definitely related to the procedure and not related to the device.The clinical end point committee (cec) adjudicated the patient bladder spasm and urinary retention as definite treatment related.The cec adjudicated the bladder spasm as possible device related and unlikely device related for the urinary retention.

Event Description

The patient underwent the study procedure and was given a prostate block, epidural, anti-anxiety and pain medication.During procedure a total of 15 treatments were performed.No device observations or adverse events occurred during treatment.The same day post procedure, the patient experienced bladder spasms for which myrbetriq (dose unknown) was administered.The bladder spasm resolved 7 days post onset symptoms.At 7 days post the index procedure, the patient started experiencing urinary retention for which craterization was performed.The urinary retention resolved 20 days post onset symptom.The investigator assessment of the patient symptom of bladder spasms and urinary retention were assessed as definitely related to the procedure and not related to the device.The clinical end point committee (cec) adjudicated the patient bladder spasm and urinary retention as definite treatment related.The cec adjudicated the bladder spasm as possible device related and unlikely device related for the urinary retention.

Manufacturer Narrative

The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.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 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: 9282226
• MDR Text Key: 165246568
• Report Number: 2937094-2019-61479
• 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: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2021
• Device Model Number: D2201
• Device Catalogue Number: D2201
• Device Lot Number: 2019020247
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 72 YR