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

Model Number	G2200
Medical Device Problem Codes	Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a water vapor therapy procedure, the generator worked for 8 seconds before encountering error code 270 (syringe empty).However, the syringe was not empty at all.There was no patient complication due to this event and the procedure was aborted.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.
Additional Manufacturer Narrative
Upon receipt of this generator at our quality assurance laboratory, it was thoroughly analyzed.Product analysis identified a damaged internal chassis, a bad wire in the internal delivery device cable and the display screen was flickering.Visual analysis identified minor plastic enclosure damage unlikely related to the reported event.The rest of the generator was in overall good physical condition.Functional testing was unable to replicate the 270 (syringe empty) error fault conditions reported.The review completed on the dhr for this generator confirmed that it met specification prior to release, and the most recent generator inspection found it to be fully functional with no issues.While the device displays 270 syringe empty was not duplicated, the damaged internal chassis and bad wire in the internal delivery device cable components could have contributed to an electrical overstress triggering the error code therefore the reported event is confirmed based on these findings.
Event or Problem Description
It was reported that during a water vapor therapy procedure, the generator worked for 8 seconds before encountering error code 270 (syringe empty).However, the syringe was not empty at all.There was no patient complication due to this event and the procedure was aborted.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.

• Brand Name: REZUM
• Common Device Name: 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: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 14047173
• Report Number: 2124215-2022-10065
• Device Sequence Number: 4908277
• Product Code: GEI
• UDI-Device Identifier: 08714729986850
• UDI-Public: 08714729986850
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K180237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2022

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
• Operator of Device: Health Professional
• Device Model Number: G2200
• Device Catalogue Number: G2200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 04/07/2022
• Supplement Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown