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 Blood Loss (2597); No Code Available (3191)

Event Date 08/06/2018

Event Type  Injury  

Manufacturer Narrative

Title: day case versus inpatient stay for excisional haemorrhoidectomy source: anz j surg 89 (2019) e5¿e9 | accepted for publication 6 august 2018.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature study performed between january 2012 to december 2017, 485 cases of excisional haemorrhoidectomy were performed.There were 170 patients who were treated as day cases and 315 patients stayed one night or longer, 20 of those used device in the procedure for day surgery and 48 for inpatient category.It was reported that there were a total of five (1.03%) readmissions, two in the day stay and three in the inpatient group, required transfusion of at least one unit of haemoglobin.Four (0.82%) readmissions, two in each group, returned to theatre for control of acute rectal bleeding.Day case versus inpatient stay for excisional haemorrhoidectomy, weisi xia, 2018, anz j surg 89 (2019) e5¿e9.

• 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: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 10655558
• MDR Text Key: 210604244
• Report Number: 1717344-2020-01181
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 47 YR