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

Model Number	G2200
Medical Device Problem Codes	Poor Quality Image (1408); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the delivery device screen flickers during use.There was unable to see anything on the display, therefore this procedure was not completed.The event occurred outside the patient, no patient complication.
Event or Problem Description
It was reported that the delivery device screen flickers during use.There was unable to see anything on the display, therefore this procedure was not completed.The event occurred outside the patient, no patient complication.
Additional Manufacturer Narrative
The rezum generator was returned to the sfmd for analysis and the reported image display artifact/distortion complaint was confirmed.The flickering display could not be duplicated during functional testing and there were no other fault conditions.As a precaution the display cables were replaced, the generator received all necessary upgrades and it passed full functional and electrical safety testing.There was a secondary finding of a broken left enclosure vent, and it was replaced.A secondary finding of damaged enclosure parts was due to normal usage wear.It can be concluded that the product operates as intended with no issues.The repairs performed were not related to the reported complaint.It was assigned a most probable cause of unintended use error caused or contributed to event.According to the device instructions for use (ifu) there is no evidence that the device was used in a manner inconsistent with the labelled indications as per rezum generator and rezum delivery device.The product investigation did not identify any potential product quality issue or any new patient harm.This investigation was assigned a most probable conclusion code of no problem detected.

• 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: 17540795
• Report Number: 2124215-2023-43234
• Device Sequence Number: 6496217
• Product Code: GEI
• UDI-Device Identifier: 08714729986843
• UDI-Public: 08714729986843
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2023

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: 0000003221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male