MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD L-SHAPE HOOK ELECTRODE 5MM32CM; ELECTROSURGICAL COAGULATION

Catalog Number	600318
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
This report is 2 of 2 for the l-shape hook electrode 5mm32cm (600318) reportedly used during this event and is related to mfg report 3014334038-2024-00236: a facility reported that during a thoracoscopy case, the "bipolar cord #600-290 was being used with our monopolar electrode/l-shape hook electrode 5mm32cm (600318) in conjunction with a covidien ft10 cautery power supply.A small fire started below the sterile field of the operating room (or) bed.Or staff was able to put out the fire and there was a brief delay in the procedure." it was reported that the procedure was completed by the provider without the use of electrocautery.No patient injury occurred.The following was subsequently reported via mdr report# mw5164071: "cautery cord (monopolar cable 10 feet) set fire while in the middle of a surgery - there was no patient or staff harm ".
Additional Manufacturer Narrative
The l-shape hook electrode 5mm32cm (600318) was not returned for evaluation after three good faith effort (gfes) attempts were made.Lot number information has been provided; device history records (dhr) were reviewed, and no anomalies related to the reported issue were identified.It was determined that a fire may be the result of damage to the monopolar cable.The cable's lot number indicates a manufacture date of 2015.Per the cable's warning label, " do not pull cord.Grasp plug to remove cable.Inspect cord prior to each use for cracks/separation.Incorrect handling of the cord can cause sparks or a fire hazard." per the cable's instructions for use (ifu) "it is very important to check all cables before each use for visual damages and wear, in particular with regard to the cord insulation.Never use damaged cables." however, a definitive root cause of the reported issue could not be determined as the product was not returned.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: L-SHAPE HOOK ELECTRODE 5MM32CM
• Common Device Name: ELECTROSURGICAL COAGULATION
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 21126772
• Report Number: 3014334038-2024-00237
• Device Sequence Number: 6957713
• Product Code: KNF
• UDI-Device Identifier: 10381780129462
• UDI-Public: 10381780129462
• Combination Product (Y/N): N
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 600318
• Device Lot Number: AB2107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 600290 MONOPOLAR CABLE 10 FEET
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White