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

Catalog Number 600290B

Device Problem Temperature Problem (3022)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that the mono cable 10 feet (600290b) sparked and the code became corrupted before the procedure.As a result, another product was used and the procedure was completed.No surgical delay or adverse consequences to the patient were observed.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

The monopolar cable (600290b) was returned for evaluation.The device history record (dhr) was reviewed, and no anomalies related to the reported issue were identified.Visual evaluation noted that the monopolar cable was in used condition with the black marks on the plug head.The head was torn or burned off of the cable.The product lot number indicates a manufacture date of 2018.This complaint may be the result of repeatedly pulling the cable by the cord rather than the plug, leading to damage and sparking as well as ripping off the head.Per the product safety warning, "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".The reported complaint was confirmed.No manufacturing, workmanship or material deficiency has been identified.

• Brand Name: MONO CABLE 10 FEET (3 METERS)
• Type of Device: 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: 15467852
• MDR Text Key: 302186070
• Report Number: 3014334038-2022-00204
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K150024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 600290B
• Device Lot Number: AN1810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1