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

Model Number D2201

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2019

Event Type  malfunction  

Event Description

It was reported that prior to a procedure the product cardboard box was found to be unsealed.The plastic top was not sealed, and the device cords were tangled and disorganized.The device was not used.The patient had not been sedated when the issue was discovered and the procedure was rescheduled.

Manufacturer Narrative

The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.Only the device was received.The device packaging was not returned for analysis so the reported allegation could not be confirmed.The information provided is not sufficient to assign a cause, therefore, an evaluation conclusion code of no problem detected was assigned to this investigation.

Event Description

It was reported that prior to a procedure the product cardboard box was found to be unsealed.The plastic top was not sealed, and the device cords were tangled and disorganized.The device was not used.The patient had not been sedated when the issue was discovered and the procedure was rescheduled.

• 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: 8839505
• MDR Text Key: 152626156
• Report Number: 2937094-2019-60952
• 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
• Type of Report: Initial,Followup
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: D2201
• Device Catalogue Number: D2201
• Device Lot Number: 2018101664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Initial Date Manufacturer Received: 07/05/2019
• Initial Date FDA Received: 07/29/2019
• Supplement Dates Manufacturer Received: 08/27/2019
• Supplement Dates FDA Received: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1