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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REZUM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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BOSTON SCIENTIFIC CORPORATION REZUM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Model Number G2200
Device Problems Defective Device (2588); Pressure Problem (3012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/03/2022
Event Type  malfunction  
Event Description
It was reported that during the self-test error 480 (sensor interface error) appeared.The device was restarted several times and error 465 (water pressure self-test error) appeared.During the procedure error 275 (syringe water fill error) appeared several times.The procedure was not completed due to this event.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.
 
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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)
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 Key15643076
MDR Text Key304786153
Report Number2124215-2022-42180
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeJO
PMA/PMN Number
K180237
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 10/20/2022
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
Device Operator Health Professional
Device Model NumberG2200
Device Catalogue NumberG2200
Device Lot Number0000004718
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/06/2022
Initial Date FDA Received10/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/20/2022
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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