MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REZUM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number G2200

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/05/2023

Event Type  malfunction  

Event Description

It was reported that during preparation for the procedure but after the patient had been sedated, the generator does not progress forward from the win screen even after rebooting.The procedure was then cancelled.Another device was brought in, and the patient was sedated again.The procedure was then completed.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.

Manufacturer Narrative

The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available, a conclusion code of cause not established was assigned to this investigation.

Manufacturer Narrative

Upon receipt of this generator at our quality assurance laboratory, the device was thoroughly analyzed.Upon powering the generator on, windows would start but would not progress beyond that point.It was determined that there was an electrical issue with the single board computer (sbc).The sbc was replaced, and the device issue resolved.The generator then passed full functional and electrical safety testing.Based on analysis results, a probable cause of cause traced to component failure was assigned to this investigation.

Event Description

It was reported that, during preparation for the procedure and following patient sedation, the generator did not progress forward from the windows screen.Rebooting the generator did not resolve the issue.The procedure was then cancelled.Another device was brought in, and the patient was sedated again.The procedure was then completed.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.

• Brand Name: REZUM
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): NORTECH SYSTEM INC; nw 7791; 1450; minneapolis MN 55485 7791
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17414083
• MDR Text Key: 319944586
• Report Number: 2124215-2023-39907
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 08714729986874
• UDI-Public: 08714729986874
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K180237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/01/2023

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 Model Number: G2200
• Device Catalogue Number: G2200
• Device Lot Number: 0000004723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2023
• Initial Date FDA Received: 07/28/2023
• Supplement Dates Manufacturer Received: 10/13/2023
• Supplement Dates FDA Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1