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	01/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 10 feet (3 meters) mono cable (600290b) was returned for evaluation.The device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.Failure analysis: visual evaluation of the cable found that the device was in used condition with the plug end broken or burned off.The product lot indicates a manufacture date of 2016.Damage or wear to the cord can lead to smoke or a fire hazard, and occur over time.Damage can also occur when pulling the cord rather than the plug, which may lead to the separation of the plug seen in this complaint.Per the label included with the product, "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 s fire hazard." root cause analysis: the reported complaint was confirmed.The returned cable was noted with the plug end broken or burned off due to wear or mishandling.No manufacturing, workmanship or material deficiency has been identified.
Event or Problem Description
It was reported that during surgery there was smoke seen coming from the 10 feet (3 meters) mono cable (600290b).The cable was replaced and the procedure continued with no delays.No patient injury occurred.

• 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: 18870873
• Report Number: 3014334038-2024-00050
• Device Sequence Number: 19585323
• 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: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/08/2024

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
• Device Lot Number: 100197-1604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2016
• 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