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

Model Number	LF4318
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Title: comparison of surgical outcomes between natural orifice transluminal endoscopic surgery for hysterectomy and conventional total laparoscopic hysterectomy source: j med assoc thai 2021;104(8):1255-62 accepted 12 july 2021.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to literature source of study performed last june 2027 to june 2020, the study objective was to compare surgical outcomes between transvaginal natural orifice transluminal endoscopic surgery for hysterectomy (vnotesh) and total laparoscopic hysterectomy (tlh) for the benign uterine diseases.A retrospective review of electronic medical records of women that underwent vnotesh with ligasure impact between january 2019 and june 2020 (n=33) and tlh between june 2017 and august 2019 (n=33) in bangkok hospital udon, udonthani province, thailand was carried out.Post-op complications of bleeding occurred in 2 (6.1%) patients in the ligasure group.

• Brand Name: LIGASURE IMPACT
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 13894609
• Report Number: 1717344-2022-00347
• Device Sequence Number: 4075160
• Product Code: GEI
• UDI-Device Identifier: 10884521165311
• UDI-Public: 10884521165311
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K123444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LF4318
• Device Catalogue Number: LF4318
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 03/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Female