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

Model Number UNKNOWN LIGASURE INSTRUMENT

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

Patient Problems Abscess (1690); Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Infection (1930)

Event Date 06/07/2020

Event Type  Injury  

Manufacturer Narrative

Title: impact of the preoperative body composition indexes on intraoperative blood loss in patients undergoing pancreatoduodenectomy source: surgery today (2021) 51:52¿60 published online: 20 june 2020.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature, a study retrospectively analyzed patients who underwent pancreatoduodenectomy between 2008 and 2019 to identify significant predictors of blood loss.The ligasure was the only device listed as being used during pd.There were 415 patients in the study and complications include: bleeding, postoperative pancreatic fistula, infection, intra-abdominal abscess, sepsis.Blood transfusions were required but no other interventions were reported.Complications not related to the device include: pneumonia, delayed gastric emptying and thrombotic/embolic events.Impact of the preoperative body composition indexeson intraoperative blood loss in patients undergoing pancreatoduodenectomy; (yukihiro yokoyama), (2020), (© springer nature singapore pte ltd.2020).

• Brand Name: UNKNOWN LIGASURE INSTRUMENT
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: 11841994
• MDR Text Key: 251187676
• Report Number: 1717344-2021-00721
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN LIGASURE INSTRUMENT
• Device Catalogue Number: UNKNOWN LIGASURE INSTRUMENT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2021
• 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
• Patient Outcome(s): Required Intervention