FDA Adverse Event Malfunction Summary report: N

ELECTROSURGICAL GENERATOR "ESG-400"

MDR report key: 14954143 · Received July 8, 2022

Report

Report Number: 9610773-2022-00256
Event Type: Malfunction
Date Received: July 8, 2022
Date of Event: June 28, 2022
Report Date: July 8, 2022
Manufacturer: OLYMPUS WINTER & IBE GMBH
Product Code: GEI
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION/INVESTIGATION BUT TO OLYMPUS (B)(4) (RETURNED TO (B)(4) ON 2022/06/30). THE EVALUATION CONFIRMED THE OCCURRENCE OF ERROR MESSAGE E433 AND TRACED THE ERROR BACK TO A DEFECTIVE GENERATOR BOARD. THUS, THE REPORTED INCIDENT CAN BE ATTRIBUTED TO COMPONENT FAILURE. IN CASE OF CRITICAL ERRORS, THE SAFETY SYSTEM WILL NOT PERMIT ANY FURTHER USE OF THE GENERATOR UNTIL THE ERROR IS RECTIFIED. A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED SERIAL NUMBER OF THE HF-GENERATOR WITHOUT SHOWING ANY ABNORMALITIES. THE CASE WILL BE CLOSED ON OLYMPUS SIDE WITH NO FURTHER ACTIONS. THE REPORTED EVENT/INCIDENT WILL BE RECORDED FOR TRENDING AND SURVEILLANCE PURPOSES. PLEASE NOTE: THIS REPORT IS BEING SUBMITTED ALTHOUGH THE SUSPECT MEDICAL DEVICE IS NOT MARKETED IN THE USA. HOWEVER, A SIMILAR DEVICE IS MARKETED. MODEL # / CATALOG #: WB91051W; BRAND NAME: ELECTROSURGICAL GENERATOR "ESG-400"; COMMON DEVICE NAME: HF-GENERATORS; 510(K): K203682; PRODUCT CODE: GEI.

Description of Event or Problem · 0

OLYMPUS WAS INFORMED THAT DURING AN INSPECTION OF A LOANER DEVICE THE ESG-400 HF-GENERATOR ISSUED ERROR CODE E433. HOWEVER, THE ERROR OCCURRED OUTSIDE A PROCEDURE AND NO PATIENT WAS INVOLVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2867192	ELECTROSURGICAL GENERATOR "ESG-400"	HF-GENERATORS	GEI	OLYMPUS WINTER & IBE GMBH	WB91051C

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown