MAUDE Adverse Event Report: OSCOR INC. MEDTRONIC REUSABLE EXTENSION CABLE; ELECTRODE CABLE

Model Number 53912

Device Problem Connection Problem (2900)

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

Event Date 09/18/2015

Event Type  malfunction  

Manufacturer Narrative

The device was in use for treatment.The cable was returned to medtronic technical services where the analysis was performed.The negative connector terminal was found pulled off of the cable and the positive connector terminal was starting to separate from the cable.A continuity test was done with test probes due to damage of the cable.The positive continuity test was okay; no intermittent connection was identified.The negative continuity tested open.Connector terminal pulled from cable.Connections were found okay when tested with probes to damaged pieces.The reported problem of cable breakage was confirmed.The instructions for use (ifu) informs the user that the cable can be re-sterilized by oscor eto gas sterilization a maximum of two times.Precautions are provided to the user: do not connect any cable model to a/c power source; connection of exposed pins to a/c power source may pose a risk of serious injury or death.Corrective and preventive action has been initiated to address this failure.

Event Description

The customer reported that the cable was breaking.No patient complications have been reported as a result of this event.

• Brand Name: MEDTRONIC REUSABLE EXTENSION CABLE
• Type of Device: ELECTRODE CABLE
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1618
• Manufacturer (Section G): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1618
• Manufacturer Contact: jan flegeau ; 3816 desoto blvd.; palm harbor, FL 34683-1618 ; 7279372511
• MDR Report Key: 5567173
• MDR Text Key: 42351662
• Report Number: 1035166-2016-00069
• Device Sequence Number: 1
• Product Code: IKD
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K070926
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/15/2016

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
• Device Operator: Physician
• Device Model Number: 53912
• Device Catalogue Number: 53912
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2016
• Initial Date FDA Received: 04/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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