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

Model Number	LF4318
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Unspecified Tissue Injury (4559)
Date of Event	11/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Title: the efficacy of ligasure¿ open instruments in cases of cesarean hysterectomy due to placenta percreta: a retrospective, record-based, comparative study source: the journal of maternal-fetal <(>&<)> neonatal medicine 1-6 published online: 30 nov 2020 if information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the literature, a retrospective study compared hysterectomies performed with traditional cutting and tying tools and th ose performed with ligasure instruments in patients with known placental insertion anomalies between 2013 and 2019.There were 28 patients in the ligasure group and post-operative complications included: transfusions, bladder repair and post-operative infection.I nterventions for bladder repair and infection not listed.The efficacy of ligasuretm open instruments in cases of cesarean hysterectomy due to placenta percreta: a retrospective, record-based, comparative study: zeyneb bakacak, 2020, taylor and francis.

• Brand Name: LIGASURE IMPACT
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 11250074
• Report Number: 1717344-2021-00138
• Device Sequence Number: 3241611
• Product Code: GEI
• UDI-Device Identifier: 10884521165311
• UDI-Public: 10884521165311
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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): 01/29/2021

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: LF4318
• Device Catalogue Number: LF4318
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 01/29/2021
• 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