FDA Adverse Event Malfunction Summary report: N

LIGASURE

MDR report key: 19513764 · Received June 11, 2024

Report

Report Number: 3006451981-2024-00070
Event Type: Malfunction
Date Received: June 11, 2024
Date of Event: May 15, 2024
Report Date: June 11, 2024
Manufacturer: COVIDIEN MEDICAL PRODUCTS
Product Code: GEI
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TW
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

CONCOMITANT PRODUCT: FORCETRIAD, FORCETRIAD FORCE TRIAD ENERGY PLATFORM, (SN: UNKNOWN) THIS PRODUCT IS NOT SOLD IN US AND IS 510(K) EXEMPT. THIS REPORT IS ASSOCIATED TO A SIMILAR PRODUCT SOLD IN THE US WITH 510(K) NUMBER K102470. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem · 0

ACCORDING TO THE REPORTER, DURING A NORMAL PROCEDURE FOR TREATING HEMORRHOIDS, THE DEVICE HAD NO SEAL (NO EVIDENCE OF ENERGY DELIVERY) WHEN THE DEVICE WAS PLUGGED INTO A GENERATOR. A NEW DEVICE WAS SUCCESSFULLY USED WITH THE SAME GENERATOR. THERE WAS NO PATIENT INJURY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
8871	LIGASURE	ELECTROSURGICAL, CUTTING & COAGULATION & ACCES	GEI	COVIDIEN MEDICAL PRODUCTS	LF1212	S0KH714X

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Male