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

Model Number LF1723

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, during a retroperitoneal tumor resection procedure, after making a few seals, the electrode on the active jaws got disengaged but nothing fell into patient's cavity.A new device was used to continue.There was no patient harm.

Manufacturer Narrative

One device sample was received for evaluation.This device had been used in the treatment or diagnosis of a patient.Without the original packaging or a reported lot number, the investigator cannot determine if the product was within the assigned expiration date at the time of reported incident.The returned product did not meet specification as received.Visual inspection found the top jaw overmold was damaged and separated away from the jaw.No missing piece.The damage to the jaw's overmold and separation likely occurred during the insertion or extraction of the device jaw from a trocar instrument.The investigation identified the root cause of the reported event to be user error.The instructions for use (ifu) states carefully insert and withdraw the instrument through the cannula to avoid damage to the device and or injury to the patient.Close jaws using device handle before insertion/extraction in the trocar.Corrective actions have been implemented to mitigate this issue.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Evaluation summary: post market vigilance led an investigation into the reported complaint in conjunction with engineering.One device was received for evaluation.The returned product did not meet specification as received.Visual inspection found the top jaw was separated from the jaw over mold.There was no missing piece.The reported condition was confirmed.The investigation found the top moving jaw was damaged.The manufacturing engineer was notified and confirmed that the product jaw b seal plate and over mold did disengage and does not meet specifications.The device appears to have been used very little.However, no root cause for the jaw b disengagement could be determined.Engineering trained the maryland line operators to be cautious with the tips of the jaws when assembling and handling the devices, and to scrap any devices that show signs of delamination.Engineering reviewed the process to determine potential root causes for delamination.Operators were cautioned to avoid contact of the jaws with assembly fixturing.This complaint will be classified as undetermined.If information is provided in the future, a supplemental report will be issued.

• 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: 7663972
• MDR Text Key: 113230974
• Report Number: 1717344-2018-00893
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521181588
• UDI-Public: 10884521181588
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133338
• 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,Followup,Followup
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LF1723
• Device Catalogue Number: LF1723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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