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

Model Number LF1937

Device Problems Retraction Problem (1536); Detachment of Device or Device Component (2907); Difficult to Open or Close (2921)

Patient Problems Radiation Exposure, Unintended (3164); Device Embedded In Tissue or Plaque (3165)

Event Date 08/07/2019

Event Type  Injury  

Manufacturer Narrative

One device was received for evaluation.Visual inspection found the device knife blade edge was damaged.There was no missing piece on the damaged knife.However an additional failure was found; the device knife blade was damaged.The investigation found the device jaw opened and closed properly when the handle was retracted and released.Further investigation found the knife blade-edge was damaged.The damage to the knife is consistent with grasping and engaging the knife blade on a hard object such as clips, staples, or other metal objects.The investigation identified the root cause of the damaged knife blade to be user error.The instructions for use (ifu) states, do not engage the cutting mechanism over clips, staples, or other metal objects as damage to the cutter may occur.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a laparoscopic assisted vaginal hysterectomy, at the 20th sealing, the doctor sealed the fallopian tube and ran the knife.After that, the doctor opened the jaws and removed the device from the tissue.The tissue was released, but the knife stopped at about 1/3 of its length of the proximal part, and the jaws got into a half-open status, not fully open.There was no tissue damaged.After operation such as squeezing the handle several times, it seemed that something flew from the jaws (on the screen).When checking the knife after taking the device out of the patient body, it seemed that the tip part was chipped.The device was never used for sealing anything hard.The customer searched for knife fragment (with the possibility of being chipped) via ct, but none was found.They used another like device to complete the procedure.

• Brand Name: LIGASURE
• 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: 8947852
• MDR Text Key: 156253678
• Report Number: 1717344-2019-01119
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 20884521705910
• UDI-Public: 20884521705910
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K170869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LF1937
• Device Catalogue Number: LF1937
• Device Lot Number: 91330372X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2019
• 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