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 Unspecified Infection (1930); Injury (2348); No Code Available (3191)

Event Date 07/29/2020

Event Type  Injury  

Manufacturer Narrative

Title: local uterine resection with bakri balloon placement in placenta accreta spectrum disorders source: turk j obstet gynecol 2020;17:108-14 | accepted: 18.05.2020.(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 2013 and december 2019 that retrospectively analyzed 97 patients who underwent surgery for placenta accreta spectrum performed at a tertiary referral medical center.A total of 97 patients were included in this study: 30 cases in the local resection group consisting of a total resection of adherent placenta and myometrium; 67 patients in the control group which was defined as cesarean hysterectomy cases.For the local resection group, the device was used to dissect the vesicouterine space.The following complications were reported: bladder injury occurred in 3 patients, pelvic vessel ligation occurred in 4 patients, 10 patients received 4 or more prbcs, wound infection in 4 patients, icu admission for 2 patients.

• 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: 10683379
• MDR Text Key: 211462210
• Report Number: 1717344-2020-01216
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• 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: 09/24/2020
• 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: 32 YR