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 07/24/2023

Event Type  malfunction  

Event Description

It was reported that during priming of a water vapor therapy procedure, the generator displayed error 275 (boot failed.Refill the syringe then reprime the delivery device).The syringe was refilled 2 times and 2 handpieces were tried but to no avail.The procedure was cancelled and postponed.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.

Event Description

It was reported that during priming of a water vapor therapy procedure, the generator displayed error 275 (boot failed.Refill the syringe then reprime the delivery device).The syringe was refilled 2 times and 2 handpieces were tried but to no avail.The procedure was cancelled and postponed.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.

Manufacturer Narrative

Upon receipt of this generator at the quality assurance laboratory, it was thoroughly analyzed.Product analysis did not identify any anomaly with the returned generator.Functional testing was performed, and the generator worked as intended.The reported error 275 (syringe water fill error) was unable to be replicated.The generator received all required updates and plastic enclosure upgrades.The review completed on the device history review (dhr) for this generator shows the generator was installed on 18 march 2020, and the most recent inspection was performed on 15 february 2021, found it to be fully functional with no issues.The performance allegation cannot be confirmed.Based on the information available, a conclusion code of no problem detected was assigned to this investigation.

• 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: 17503010
• MDR Text Key: 321148948
• Report Number: 2124215-2023-41980
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 11/17/2023

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2023
• Initial Date FDA Received: 08/10/2023
• Supplement Dates Manufacturer Received: 11/16/2023
• Supplement Dates FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1