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

Model Number D2201

Device Problems Material Fragmentation (1261); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/19/2019

Event Type  malfunction  

Event Description

It was reported that during convective radiofrequency water vapor thermal therapy treatment of the prostate, while delivering the 10 th treatment, a plastic flaking off was able to be seen inside the patient.The material was flushed out of the patient's body.The procedure was completed utilizing the same device without clinical consequences to the patient.

Manufacturer Narrative

The returned device was disassembled and the fragmented piece was identified to come from the silicon duck bill that the scope enters through in the back of the device.This was most likely caused by the scope being pushed in with too much force or pushed in at a non-linear angle.A review of the device history record confirmed that the device met all material, assembly and performance specifications prior to release.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.Based on the analysis results, the information provided is not sufficient to assign a cause, therefore, the investigation conclusion code is cause not established.

Event Description

It was reported that during convective radiofrequency water vapor thermal therapy treatment of the prostate, while delivering the 10th treatment, a plastic flaking off was able to be seen inside the patient.The material was flushed out of the patient's body.The procedure was completed utilizing the same device without clinical consequences to the patient.

• 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: 8620703
• MDR Text Key: 145406447
• Report Number: 2937094-2019-60634
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Date Manufacturer Received: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1