MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORP. INTEGRA JARIT MONOPOLAR CABLE

Catalog Number 600-290

Device Problems Detachment Of Device Component (1104); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/18/2017

Event Type  Injury  

Event Description

Incident #2 of 2.On (b)(6) 2017.The monopolar cautery cord was completely severed from where it was attached to the bovie machine and the rest of the cord was dangling on the floor from the patient/sterile field.No sparks were seen, according to the surgeon, assistant, and surgical tech, the monopolar cautery cord was not currently in use when it occurred.The tech did mention, however, that he heard a pop and then the surgeon stated that something fell (which was the remainder of the cord.) the cord along with the attachment was removed, inspected further, disinfected, and put aside in a bag.The cord was replaced with another that was feel-packed.Ref # mw5069372.

• Brand Name: INTEGRA JARIT MONOPOLAR CABLE
• Type of Device: INTEGRA JARIT MONOPOLAR CABLE
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP.; plainsboro NJ 08536 3344
• MDR Report Key: 6526235
• MDR Text Key: 74044152
• Report Number: MW5069373
• Device Sequence Number: 1
• Product Code: KNF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 600-290
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention