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

Model Number	G2200
Medical Device Problem Codes	Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a delivery device error message displayed up during preparation for the procedure and required set up twice.After second set up syringe cradle wasn't registering syringe in place.A second delivery device was opened and the same issue occurred.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.
Event or Problem Description
It was reported that a delivery device error message displayed up during preparation for the procedure and required set up twice.After second set up syringe cradle wasn't registering syringe in place.A second delivery device was opened and the same issue occurred.The procedure was then cancelled/rescheduled.The patient had been administered general anesthesia.
Additional Manufacturer Narrative
Investigation summary with the available information boston scientific corporation concluded based on analysis results, that the reported error message that led to the procedure being cancelled was unable to be replicated.It can be concluded that the generator operated as intended.The observed display static was probable due to the cables as replacing them resolved the static.The sticky cradle and enclosure damage were due to normal usage.These identified static, sticky cradle and enclosure damage observations are unrelated to the reported event and unlikely to have contributed to the reported event.A review of the generator service history confirmed that the generator was fully functional without issues since installation.Device history review: a service history review was completed.This generator was installed on 21 august 2019.The generator was fully functional without any issues.Device technical analysis: the generator was returned for analysis and repaired.During functional testing of the generator no error messages were identified.The generator passed the power on self-test (post).A test syringe and delivery device were connected to the generator without issues.The generator, primed and flushed, as intended.The syringe cradle was observed to be sticking during functional testing; therefore, the plastic was replaced with updated plastic to correct this issue.Static was observed on the display screen, the motor cables were replaced and upgraded to the latest version.Minor damage to the plastic enclosure was also observed and it was replaced.No other anomalies were identified.The generator passed full functional and electrical safety testing.Investigation conclusion: based on analysis results an evaluation conclusion code of no problem detected was assigned to this investigation as there were no damaged identified during analysis that could have caused or contributed to the reported error message.The reported event cannot be 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: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 12688542
• Report Number: 2124215-2021-32196
• Device Sequence Number: 1389447
• Product Code: GEI
• UDI-Device Identifier: 08714729986850
• UDI-Public: 08714729986850
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 02/08/2022

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
• Device Lot Number: 0000003161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 10/25/2021
• Supplement Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Male