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

Model Number	G2200
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had been given general anesthesia prior to a water vapor therapy procedure.During preparation for the procedure.Error 455 (saline pump self-test error) occurred.The unit was turned off and then on again, but the error did not resolve.The procedure was then cancelled.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.
Event or Problem Description
It was reported that the patient had been given general anesthesia prior to a water vapor therapy procedure.During preparation for the procedure.Error 455 (saline pump self-test error) occurred.The unit was turned off and then on again, but the error did not resolve.The procedure was then cancelled.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.
Additional Manufacturer Narrative
Upon receipt of this generator, this device was thoroughly analyzed.Analysis of the generator was able to replicate error 455 intermittently.The insulation on the wire of the peristatic pump was found to be damaged.The conductors were exposed.The saline pump and wiring harness were replaced.The generator was in overall good physical condition, and it passed full functional and electrical safety testing.Based on analysis results, the reported event was confirmed.

• 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: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 16464157
• Report Number: 2124215-2023-09613
• Device Sequence Number: 6458689
• Product Code: GEI
• UDI-Device Identifier: 00855357006003
• UDI-Public: 00855357006003
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2023

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
• Operator of Device: Health Professional
• Device Model Number: G2200
• Device Catalogue Number: G2200
• Device Lot Number: 0000005148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2023
• Supplement Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown