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

Model Number UNKNOWN LIGASURE INSTRUMENT

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

Patient Problems Abdominal Pain (1685); Perforation (2001); Peritonitis (2252); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Death  

Manufacturer Narrative

Title: intra-abdominal rectal perforation post-haemorrhoidal artery ligation operation and converted ligasure open haemorrhoidectomy.Source: journal of surgical case reports, 2021;7, 1¿3.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature study, a (b)(6) year old woman underwent hemorrhoid artery ligation operation (halo) which was converted to an open ligasure hemorrhoidectomy.Postoperative complications included: rectal perforation.She was readmitted 5 days post-discharge for abdominal pain, underwent ct(computer tomography) scan and urgent laparoscopy which showed pus and peritonitis.Surgery was converted to laparotomy and showed a rectal perforation.Bowel resection with end colostomy was performed.She was admitted to the icu (intensive care unit), but deteriorated and died 14 days later of multi-organ failure.

• Brand Name: UNKNOWN LIGASURE INSTRUMENT
• Type of Device: 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: 12481139
• MDR Text Key: 271686123
• Report Number: 1717344-2021-01278
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• 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: 08/20/2021
• 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): Death; Hospitalization; Required Intervention
• Patient Age: 74 YR