MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER LIGASURE PRECISE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number	LS1200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Title: perioperative outcomes of ligasure versus standard ligasure technique among overweight and obese women undergoing abdominal hysterectomy: a randomized clinical trial source: journal of gynecologic surgery volume 37, number 4, 2021.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the literature, a study compared compare outcomes of ligasure (ls1200) versus standard ligature technique among women undergoing abdominal hysterectomy between january 2018 and january 2020.There were 90 patients in the study: 45 in the ligasure group (group ii) and 45 in the traditional technique group (group i).Ligasure group postoperative complications included: postoperative bloodloss (blood in the intra-abdominal drain), bladder injury (1 %) and vessel injury (1 %).Blood transfusion (1%) was required.

• Brand Name: LIGASURE PRECISE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 12633570
• Report Number: 1717344-2021-01412
• Device Sequence Number: 14583265
• Product Code: GEI
• UDI-Device Identifier: 10884524001463
• UDI-Public: 10884524001463
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K010010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,l
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LS1200
• Device Catalogue Number: LS1200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2021
• Initial Report FDA Received Date: 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR