MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RF3000 RADIOFREQUENCY GENERATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 36739

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 05/26/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).

Event Description

It was reported that roll-off was not achieved.A rf3000 radiofrequency generator was selected for use.During the case, the rf3000 radiofrequency generator was working really slow and roll off was not achieved.The procedure was completed with the original device.

• Brand Name: RF3000 RADIOFREQUENCY GENERATOR
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): STELLARTECH RESEARCH CORPORATION; 560 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12068352
• MDR Text Key: 258685708
• Report Number: 2134265-2021-08057
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 36739
• Device Catalogue Number: 36739
• Device Lot Number: 013009-013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2009
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1