MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS LIGASURE ATLAS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number LS1037

Device Problems Entrapment of Device (1212); Difficult to Open or Close (2921)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 07/13/2022

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during laparoscopically assisted vaginal hysterectomy (lavh), the handle was squeezed on first bite on a less than 7mm bladder flap and was not able to open.The tissue was not under tension.The knife blade was not extended.A harmonic was used to cut around tissue as it was locked to remove ligasure.After the procedure, the handle was opened using force and it was opening and closing normally.There was no blood loss and no patient injury.

• Brand Name: LIGASURE ATLAS
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CH 201114
• Manufacturer (Section G): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CH 201114
• Manufacturer Contact: covidien landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 15117399
• MDR Text Key: 296748748
• Report Number: 3006451981-2022-00073
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884524001630
• UDI-Public: 10884524001630
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LS1037
• Device Catalogue Number: LS1037
• Device Lot Number: S1F0108X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2022
• Date Device Manufactured: 06/21/2021
• 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
• Patient Age: 50 YR
• Patient Sex: Female