COBLATOR II Controller 120V (SRVC controller-only) 13546-59Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00817470001792), received between Jun 21, 2020 and Jul 13, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Defective Component” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K030108); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE COBLATOR CONTROLLER WAS NOT WORKING. IT IS UNKNOWN WHEN THE ISSUE WAS DISCOVERED, IF A DELAY HAPPENED AND IF A BACKUP DEVICE WAS AVAILABLE. HOWEVER, NO PATIENT INJURIES WERE REPORTED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT DOES NOT RECOGNIZE THE WAND WHICH MAKES IT A REPORTABLE EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10268534 ↗
• MalfunctionJul 7, 2020Defective Component; Defective Component

  IT WAS REPORTED THAT THE FOOT PEDAL INSERTION WAS PUSHED ON, THE GENERATOR WAS INOPERABLE. IT IS UNKNOWN WHETHER THERE WAS A BACK UP AVAILABLE OR DELAY IN THE CASE AND IF THE EVENT HAPPENED DURING SURGERY. NO PATIENT INJURIES WERE REPORTED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD THE FOOT PEDAL PORT DAMAGED WHICH MAKES IT A REPORTABLE EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10239823 ↗
• MalfunctionJun 21, 2020Defective Component; Defective Component

  IT WAS REPORTED THAT THE CONTROLLER CONNECTOR FOR THE FOOT SWITCH WAS DAMAGED. NO CASE OR PATIENT INVOLVED. WAS INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10177246 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K030108. One submission often covers many models, so check the product and lot details in each record.

• Z-1323-2015 · Feb 20, 2015 · Terminated
  Coblator II System, 120V. Product Usage: The Coblator II (Model RF8000E) is a bipolar, radiofrequency electrosurgical system designed for use in otorhinolaryngology (ENT) surger