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

Model Number LF2019

Device Problems Detachment Of Device Component (1104); Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2018

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 thyroidectomy procedure, the insulation tip of the device was found damaged and chipped but nothing fell into patient's cavity.The device was used to complete the procedure since the device was activated without any issue however the chipped piece was nowhere to be found.There was no patient injury.

Manufacturer Narrative

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

Manufacturer Narrative

Evaluation summary: the product was not returned; however, a picture was provided by the customer for analysis.This device had been used in the treatment or diagnosis of a patient.A review of the lot number reported indicates that the product was within the assigned expiration date at the time of the reported incident.The returned product did not meet specification as received because of the broken tip of the jaw.Photographic inspection found that the plastic tip fractured on one jaw.The reported condition was confirmed.From the pictures, it might be concluded that the plastic tip was broken by damage from an external force.Manufacturing and supplier were ruled out as the cause of the fracture by the engineering.The exact cause of the damage could not be determined.The customer indicated that the broken tip did not disengage from the device into the cavity.Engineering tested unused devices and could not replicate the mechanical damage to the tip by applying various types of forces.The investigation could not determine the root cause of the customer complaint.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 lf2019 was received for evaluation.Visual inspection revealed that the plastic tip fractured on one jaw.The device was heavily used.It appears that the plastic tip was broken by damage from an external force.Manufacturing and supplier were ruled out as the cause of the fracture by the engineering.The exact cause of the damage could not be determined.The customer indicated that the broken tip did not disengage from the device into the cavity.Engineering tested unused devices and could not replicate the mechanical damage to the tip by applying various types of forces.The investigation could not determine the root cause of the customer complaint.If information is provided in the future, a supplemental report will be issued.

• Brand Name: LIGASURE EXACT
• 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 dr.; boulder, CO 80301 ; 2034925563
• MDR Report Key: 7664485
• MDR Text Key: 113282291
• Report Number: 1717344-2018-00897
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 20884521741093
• UDI-Public: 20884521741093
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 10/10/2018

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 Expiration Date: 03/12/2020
• Device Model Number: LF2019
• Device Catalogue Number: LF2019
• Device Lot Number: 80720113X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2018
• 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