P CORD MAJ-814Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170078361), received between Dec 9, 2018 and Oct 9, 2024 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 9, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS NOT IN CONTACT WITH ANY METAL OBJECTS DURING THE PROCEDURE. HOWEVER, THE PATIENT WAS LAYING ON A GROUNDED OPERATING TABLE THAT INCLUDED ADDITIONAL METAL COMPONENTS. THE PATIENT'S LEFT THIGH WAS NOT HAIRY AND THE PAD REMAINED ATTACHED THROUGHOUT THE PROCEDURE. THE SETTINGS ON THE GENERATOR WERE SET ACCORDING TO OLYMPUS AND NO ALARM SOUNDED. THE PATIENT DID NOT HAVE ANY METAL IMPLANTS AND NO ADDITIONAL BURNS WERE FOUND ON THE PATIENT. FURTHERMORE, IT WAS REPORTED THE CUSTOMER HAS BEEN USING OLYMPUS CABLES FOR 3-5 YEARS.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 20411692 ↗
• MalfunctionDec 9, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  THE USER ATTACHED THE PATIENT PLATE (ELECTRODE PLATE) ON THE RIGHT BUTTOCK OF THE PATIENT IN THE ENDOSCOPIC PROCEDURE OF USING HIGH FREQUENCY CURRENT. DURING THE PROCEDURE, THE PATIENT FELT A SENSE OF NUMBNESS. THERE WAS NO PROBLEM THAT ATTACHMENT OF THE PATIENT PLATE ON THE PATIENT'S BODY, AND CONNECTION OF THE PATIENT PLATE AND THE SUBJECT MAJ-814. THERE WAS NO REPORT OF THE PATIENT¿S INJURY REGARDING THIS EVENT.

  Patient problems: Numbness

  MAUDE report 8145290 ↗