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

Model Number G2200

Device Problems Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/08/2022

Event Type  malfunction  

Event Description

It was reported that unit is consistently giving error messages (priming cycle would not complete) during the device prime stage.Procedure was not performed, and patient was already sedated under general anesthesia.There were no patient complications reported.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.

Event Description

It was reported that unit is consistently giving error messages (priming cycle would not complete) during the device prime stage.Procedure was not performed, and patient was already sedated under general anesthesia.There were no patient complications reported.This event is being reported for aborted/cancelled procedure with a patient under general anesthesia.

Manufacturer Narrative

Upon receipt of this generator at the sfmd quality assurance laboratory, this device was thoroughly analyzed.The service department was able to confirm error codes 265 (pressure value below 250 mmhg during vapor generation) and 480 (readings from one of the three analog temp sensors and the pressure sensor are zero or negative) from the event logs.An electrical fault was determined.Also, the display screen was identified to be flickering.The load cell, mcu (master control board), sensor/relay harness and the display cables were replaced, resolving the issue.The generator received all required updates as per upgrade checklist 3401.1802-004rcheck.It passed full functional and electrical safety testing.Based on all available information, the most probable cause was determined to be cause traced to component failure.It is likely that an electrical failure caused or contributed to the reported allegations.

• 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: 16018089
• MDR Text Key: 306377177
• Report Number: 2124215-2022-53628
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• 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: 0000003238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1