MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD MONO CABLE 10 FEET (3 METERS); PFM16

Catalog Number	600290B
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that during a case that was underway, the surgeon was using the mono cable 10 feet (3 meters) (600290b), and the nurse reported that she smelled "something burning, and then heard a pop, and the cable had broken apart." there was no patient injury or death reported; however, a couple of minutes delay was noted to replace the broken cord.
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
N/a.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h6, h11.600290b mono cable 10 feet was returned for evaluation.Failure analysis: the returned monopolar cable was received in used condition, with the end broken off along the cable.The product lot indicates a manufacture date of 2019.Damage to the cable and insulation may be the result of wear or pulling by the cord instead of the plug.Damage will lead to smoking and fire hazard.Per the product warning label, "do not pull cord.Grasp the plug to remove the cable.Inspect the cord prior to each use for cracks/separation.Incorrect handling of the cord can cause sparks or a fire hazard." per the cable's information for use (ifu, jl-00107), "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." root cause analysis: the reported complaint was confirmed.The product lot number indicates a manufacturing date of 2019.Per the ifu and product warning label, damaged cables could pose a fire hazard and must not be used.No manufacturing, workmanship, or material deficiency has been identified.

• Brand Name: MONO CABLE 10 FEET (3 METERS)
• Common Device Name: PFM16
• 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: 23018372
• Report Number: 3014334038-2025-00125
• Device Sequence Number: 21210222
• Product Code: GEI
• UDI-Device Identifier: 10381780150718
• UDI-Public: (01)10381780150718
• 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): 10/14/2025

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: 600290B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2019
• 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
• Patient Sex: Unknown