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

Model Number	G2200
Medical Device Problem Codes	Retraction Problem (1536); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a during a water vapor therapy procedure for benign prostatic hyperplasia, four kits were opened and with all of them, the generator displayed error code 296 faulty delivery device: needle retraction error.The manual retraction was successful, but the needle would not re deploy.The generator was turned on and off, but the procedure could not be completed.There were no patient complications.This event is being reported for an aborted/cancelled procedure with a patient under general anesthesia.
Additional Manufacturer Narrative
Upon receipt of this generator at our quality assurance laboratory, the device was thoroughly analyzed.The reported error 296 (faulty delivery device-needle retraction error) was unable to replicate and there were no error codes prompted during the functional testing.The device passed the power on self-test, and the syringe and delivery device were connected without problems.However, the event log was check and it was identified that the error code 296 was recorded several times confirming the event experienced by the customer.The issue reported that could be due to an electrical failure.The internal delivery device cable and the master control board (mcu) were replaced, and the generator was fully updated, therefore all the functional and electrical safety testing were successful.
Event or Problem Description
It was reported that during a during a water vapor therapy procedure for benign prostatic hyperplasia, three kits were opened and with all of them, the generator displayed error code 296 faulty delivery device: needle retraction error.The manual retraction was successful, but the needle would not re deploy.The generator was turned on and off, but the procedure could not be completed.There were no patient complications.This event is being reported for an aborted/cancelled procedure with a patient under general anesthesia.
Event or Problem Description
It was reported that during a during a water vapor therapy procedure for benign prostatic hyperplasia, four kits were opened and with all of them, the generator displayed error code 296 faulty delivery device: needle retraction error.The manual retraction was successful, but the needle would not re deploy.The generator was turned on and off, but the procedure could not be completed.There were no patient complications.This event is being reported for an aborted/cancelled procedure with a patient under general anesthesia.
Additional Manufacturer Narrative
Boston scientific concludes that the reported allegations in this complaint have not been confirmed, as the product was not returned for analysis.Without a returned device, no physical or visual analysis of the product could be performed.Based on the information available, a conclusion code of cause not established was assigned to this investigation.

• 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): NORTECH SYSTEM INC; nw 7791; 1450; minneapolis MN 55485 7791
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18645412
• Report Number: 2124215-2024-05766
• Device Sequence Number: 18211893
• Product Code: GEI
• UDI-Device Identifier: 08714729986850
• UDI-Public: 08714729986850
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/20/2024

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: 0000003872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/29/2024
• Supplement Date Received by Manufacturer: 02/12/2024; 03/18/2024
• Initial Report FDA Received Date: 02/05/2024
• Supplement Report FDA Received Date: 02/27/2024; 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown