A CORD MH-969Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170048548), received between Jan 20, 2020 and Jan 20, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2020Break; Sparking; Break; Sparking

  THE SERVICE CENTER RECEIVED A REPORT THAT A MH-969, LOT NUMBER UNKNOWN, SPARKED AND SNAPPED IN HALF DURING A PROCEDURE. IT WAS REPORTED THAT A PHYSICIAN WAS USING THE MH-969 WITH A GENERATOR WHEN THE PHYSICIAN STEPPED ON A PEDAL TO ACTIVATE THE DEVICE AND THE MH-969 ORIGINALLY DID NOT WORK. UNEXPECTEDLY, AFTER A SHORT PERIOD OF TIME, THE MH-969 SPARKED AND SNAPPED IN HALF. THE PHYSICIAN REPLACED THE MH-969 AND THE GENERATOR AND COMPLETED THE UNSPECIFIED PROCEDURE AFTER A DELAY IN THE INTENDED PROCEDURE TO REPLACE THE EQUIPMENT. IT WAS REPORTED THERE WAS NO PATIENT DEATH OR INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9608392 ↗