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

Model Number	600290B
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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
A facility reported that the mono cable 10 feet (600290b) burned while in use, at generator end (not the patient end).The cord was visibly smoking and was immediately removed from use.It was reported that no one was harmed and the surgeon had just finished using it for the remainder of the case.No increase in surgery time occurred as a result of the event.
Additional Manufacturer Narrative
The mono cable 10 feet (3 meters) (600290b) has not been returned to the manufacturer after evaluation after three good faith effort (gfe) attempts to retrieve the product.Lot number information has not been provided; therefore, a review of the device history record (dhr) could not be performed.Definitive root cause cannot be determined.The issue of burning may result from mishandling of the cord.Per the product safety label, "do not pull the 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".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: MONO CABLE 10 FEET (3 METERS)
• Common Device Name: PFM16
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 16640577
• Report Number: 3014334038-2023-00035
• Device Sequence Number: 6097302
• Product Code: GEI
• UDI-Device Identifier: 10381780150718
• UDI-Public: 10381780150718
• Combination Product (Y/N): N
• PMA/510(K) Number: K150024
• 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): 04/24/2023

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 Model Number: 600290B
• Device Catalogue Number: 600290B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/03/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 04/24/2023
• 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