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

Model Number G2200

Device Problem Defective Device (2588)

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

Event Date 12/20/2023

Event Type  malfunction  

Event Description

It was reported that during preparation, after the patient was under lumbar anesthesia, the error 275 occurred while priming.The setup was redone, and the delivery device was replaced, however, the event persisted and generator error 480 also occurred thereafter.The procedure was cancelled and rescheduled for the next day.No patient complications were reported.

Event Description

It was reported that during preparation, after the patient was under lumbar anesthesia, the error 275 occurred while priming.The setup was redone, and the delivery device was replaced, however, the event persisted and generator error 480 also occurred thereafter.The procedure was cancelled and rescheduled for the next day.No patient complications were reported.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.

Manufacturer Narrative

Upon receipt at our quality assurance laboratory, the returned generator underwent a thorough analysis.The service department was unable to replicate the 275: empty limit switch indicates the syringe limit is empty and 480: readings from one of the three analog temp sensors.No error codes appeared during the incoming functional testing.The generator passed the power on self-test.Syringe and delivery device were connected with no issues.The generator primed and flush as per specifications and was in overall good physical condition.All functional and electrical safety testing were completed without any abnormality detected.This investigation was assigned a most probable conclusion code of no problem detected.

• 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): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18430128
• MDR Text Key: 331896009
• Report Number: 2124215-2023-74187
• 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: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1