FDA Adverse Event Malfunction Summary report: N

OLYMPUS ACTIVE CORD

MDR report key: 2539618 · Received April 6, 2012

Report

Report Number: 8010047-2012-00114
Event Type: Malfunction
Date Received: April 6, 2012
Report Date: March 9, 2012
Manufacturer: OLYMPUS MEDICAL SYSTEM CORPORATION
Product Code: FFZ
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OR, US
Reporter Occupation: BIOMEDICAL ENGINEER

Narratives

Additional Manufacturer Narrative · 1

THE ACTIVE CORD REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE ACTIVE CORD WAS RECEIVED IN TWO PIECES, AS THE CORD WAS DETACHED FROM THE HANDPIECE CONNECTOR. IN ADDITION, THERE WERE EVIDENCE OF TOOLS INDENTATIONS ON THE SURFACE OF THE CABLE CONNECTOR. THERE WERE EVIDENCE OF ELECTRICAL ARCING AND STAINING ON THE SURFACE OF THE SIGNAL WIRES LOCATED AT THE DETACHMENT POINT. THE DEVICE WAS FORWARDED TO THE ORIGINAL EQUIPMENT MFR (OEM) FOR FURTHER INVESTIGATION. THE EXACT CAUSE OF THE USER'S EXPERIENCE COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, USE OF A NON-OLYMPUS GENERATOR OR THE DEVICE SETTINGS COULD NOT BE RULED OUT AS CONTRIBUTORY FACTORS TO THE REPORTED EVENT. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE IN AN ABUNDANCE OF CAUTION.

Description of Event or Problem · 1

THE USER FACILITY REPORTED THAT THE ACTIVE CORD CAUGHT FIRE WHILE BEING TESTED WITH A NON-OLYMPUS ELECTROSURGICAL UNIT (ERBE) AND OUTPUT ANALYZER. THE BIOMED AT THE FACILITY REPORTED THAT THE PURPOSE OF THE TEST WAS TO CHECK THE ELECTROSURGICAL UNIT DUE TO USER'S REPORT OF THE DEVICE NOT WORKING CORRECTLY AND HAVING A DIFFERENT TONE DURING USE. THERE WAS NO PT OR USER INJURY REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OLYMPUS ACTIVE CORD	ACTIVE CORD	FFZ	OLYMPUS MEDICAL SYSTEM CORPORATION	MH-969	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK			ERBE ELECTROSURGICAL UNIT\| AND OUTPUT ANALYZER.