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

Model Number G2200

Device Problems Defective Device (2588); Pressure Problem (3012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2022

Event Type  malfunction  

Event Description

It was reported that during the self-test, error 480 (sensor interface error) occurred.The generator was restarted several times then error 465 (water pressure self-test error) occurred.After restarting a few more times, the generator was able to work properly.During the procedure, an error indicating to refill the syringe while the syringe was full occurred three times.The generator was restarted and at that point, error 275 (syringe water fill error) kept occurring during priming.The patient was under general anesthesia and the procedure was cancelled due to this event.It was noted that after the procedure, the generator was tested at the customer office and error 275 (syringe water fill error) occurred several times.In addition, error 240 (low water pressure (prime)), error 275 (syringe water fill error) and error 465 (water pressure self-test error) repeated.This event is being reported for cancelled procedure with a patient under anesthesia.

Manufacturer Narrative

The generator was returned for analysis.During inspection, the event logs were reviewed.The reported device displays 275 syringe water fill error, device displays 465 water pressure self-test error, device displays 240 low water pressure (prime) and device displays 480 sensor interface error complaints were confirmed from the event log.The issue was resolved during the needed upgrades to the generator.Once all required upgrades were completed, the generator passed full functional and electrical safety testing.The product record review did not identify any potential product quality issue or any new patient harm.Therefore, it can be concluded that the electrical failure was the most probable cause of the reported observation.

Event Description

It was reported that during the self-test, error 480 (sensor interface error) occurred.The generator was restarted several times then error 465 (water pressure self-test error) occurred.After restarting a few more times, the generator was able to work properly.During the procedure, an error indicating to refill the syringe while the syringe was full occurred three times.The generator was restarted and at that point, error 275 (syringe water fill error) kept occurring during priming.The patient was under general anesthesia and the procedure was cancelled due to this event.It was noted that after the procedure, the generator was tested at the customer office and error 275 (syringe water fill error) occurred several times.In addition, error 240 (low water pressure (prime)), error 275 (syringe water fill error) and error 465 (water pressure self-test error) repeated.This event is being reported for cancelled procedure with a patient under anesthesia.

• Brand Name: REZUM
• Type of Device: 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: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 15959708
• MDR Text Key: 307929064
• Report Number: 2124215-2022-51307
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: JO
• PMA/PMN Number: K180237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/20/2023

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
• Device Operator: Health Professional
• Device Model Number: G2200
• Device Catalogue Number: G2200
• Device Lot Number: 0000004718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2022
• Initial Date FDA Received: 12/12/2022
• Supplement Dates Manufacturer Received: 09/08/2023
• Supplement Dates FDA Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 58 YR