MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS LIGASURE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number LF1212

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Stenosis (2263)

Event Date 03/31/2023

Event Type  malfunction  

Manufacturer Narrative

D10 concomitant product: lf1212 sml ligasure jaw sealer/div (lot#: unknown); lf1212 sml ligasure jaw sealer/div (lot#: unknown) further review of the event found that the involved product is not sold within the united states.No further reports will be sent for this event.Claudio gambardella, luigi brusciano, antonio brillantino, simona parisi, francesco saverio lucido, gianmattia del genio, salvatore tolone, alfredo allaria, salomone di saverio, francesco pizza, alessandro sturiale, ludovico docimo.Mid-term efficacy and postoper ative wound management of laser hemorrhoidoplasty (lhp) vs conventional excisional hemorrhoidectomy in grade iii hemorrhoidal disease: the twisting trend.Langenbeck's archives of surgery (2023) 408.Https://doi.Org/10.1007/s00423-023-02879-4.Page 140 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature, a retrospective study compared the safety and effectiveness of laser hemorrhoidoplasty with conventional milligan-morgan hemorrhoidectomy in treatment of patients with iii degree hemorrhoidal disease between (b)(6) 2018 and (b)(6) 2019.In the conventional group, the device or a competitor device was used to perform the hemorrhoidectomy.There were 93 patients in the conventional group and postoperative complications included: anal stenosis and other post defecatory bleeding.Two patients reported mild anal stenosis while post defecatory bleeding occurred in 58 patients, all cases were conservatively managed.

Manufacturer Narrative

Correction: 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 is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: LIGASURE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai CO 20111 4; CH 201114
• Manufacturer (Section G): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai CO 20111 4; CH 201114
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 17953696
• MDR Text Key: 326393834
• Report Number: 1717344-2023-01281
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LF1212
• Device Catalogue Number: LF1212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE NOTE ON H10
• Patient Age: 43 YR
• Patient Sex: Female