MAUDE Adverse Event Report: NORTECH SYSTEMS REZUM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	G2200
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that due to heat and syringe errors, the procedure could not be completed.The device was confirmed to be in good condition after preparation.No additional information was provided.
Event or Problem Description
It was reported that due to heat and syringe errors, the procedure could not be completed.The device was confirmed to be in good condition after preparation.There were no patient complication and the patient status is reported as good following this aborted procedure.No patient complications were reported following the procedure.
Additional Manufacturer Narrative
Investigation summary: with all the available information, boston scientific concludes that the reported event cannot be confirmed.Analysis of the returned generator did not identify any damages that could have caused or contribute to the reported event.The review from the product record review confirmed that the generator met specification prior to release and there was no patient harm due to the reported event.There was no information to reasonably suggest that the as reported event could potentially cause or contribute to a death or serious injury if the malfunction were to reoccur.Device history record (dhr): a review of the dhr confirmed that the device met all material, assembly and performance specification.Device technical analysis: the generator was returned and upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.Visual inspection of the generator found a minor plastic enclosure damage.The part was replaced.During functional testing, the reported event could not be replicated.The generator passed full functional and electrical safety testing.Labeling review: review of the complaint information and the generator instruction for use manual did not reveal any evidence of device off-label use or failure to follow instructions.Investigation conclusion: based on analysis results a conclusion code of no problem detected was assigned to this investigation.
Event or Problem Description
It was reported that due to heat and syringe errors, the procedure could not be completed.The device was confirmed to be in good condition after preparation.There were no patient complication and the patient status is reported as good following this aborted procedure.No patient complications were reported following the procedure.

• Brand Name: REZUM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): NORTECH SYSTEMS; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11317995
• Report Number: 2937094-2021-00114
• Device Sequence Number: 19864872
• Product Code: GEI
• UDI-Device Identifier: 08714729986850
• UDI-Public: 08714729986850
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/05/2021

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: 01/28/2021
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 02/11/2021; 03/31/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 03/07/2021; 04/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1