FDA Adverse Event Injury Summary report: N

LIGASURE

MDR report key: 12632062 · Received October 14, 2021

Report

Report Number: 1717344-2021-01405
Event Type: Injury
Date Received: October 14, 2021
Date of Event: August 12, 2021
Report Date: October 14, 2021
Manufacturer: COVIDIEN MFG DC BOULDER
Product Code: GEI
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IT
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

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. TITLE: OPEN HEMORRHOIDECTOMY WITH LIGASURE¿ UNDER LOCAL OR SPINAL ANESTHESIA: A COMPARATIVE STUDY SOURCE: THE AMERICAN SURGEON 2021, VOL. 0(0) 1¿5 © THE AUTHOR(S) 2021 ARTICLE REUSE GUIDELINES: SAGEPUB.COM/JOURNALS-PERMISSIONS DOI: 10.1177/00031348211038590 JOURNALS.SAGEPUB.COM/HOME/ASU. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

ACCORDING TO THE LITERATURE, A STUDY ANALYZED OUTCOMES OF PATIENTS WITH GRADE III OR IV HEMORRHOIDS WHO UNDERWENT OPEN HEMORRHOIDECTOMY WITH LIGASURE UNDER LOCAL OR SPINAL ANESTHESIA BETWEEN 2018 AND 2020. THERE WERE 62 PATIENTS IN THE STUDY: 32 PROCEDURES WERE PERFORMED UNDER SPINAL ANESTHESIA AND 30 WERE PERFORMED UNDER LOCAL ANESTHESIA. POSTOPERATIVE COMPLICATIONS INCLUDED BLEEDING. THERE WERE 5 CASES OF BLEEDING: TWO BETWEEN 250-500CC. TWO PATIENTS REQUIRED URGENT REINTERVENTION. REOPERATIONS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1529923	LIGASURE	ELECTROSURGICAL, CUTTING & COAGULATION & ACCES	GEI	COVIDIEN MFG DC BOULDER	LF1212

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other