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 02/26/2016

Event Type  malfunction  

Manufacturer Narrative

The device was in use for treatment.One atar 53912 extension cable was returned from the customer with no other accessories.No visible blood was found anywhere on the extension cable.A review of the device history record for this cable could not be performed as the lot number is unknown.Returned device analysis revealed that the atar extension cable was within manufacturing specification.Visual inspection found the cable faded/discolored.While checking the resistance through each cable it was found that there was no connection between the black connector and the female mdt connector.After removing the strain relief it was found that the wires broke at the solder joint causing the shrouded connector to lose connection.After analyzing these pins it was found that the strain relief looked warped.After cutting open the strain relief, signs of stress/stretching on the inside were noted.The stress/stretching is occurring right at the solder joint and is acting as a pivot point anytime the cables are handled.Even though there is a strain relief on the parts, they do not reduce the force on the joint enough to prevent failure.Corrective and preventive action has been opened to address this failure.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.

Event Description

The customer reported that the extension cable has an open black wire.There was no report of any patient adverse effects from 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: 5507481
• MDR Text Key: 40570537
• Report Number: 1035166-2016-00033
• Device Sequence Number: 1
• Product Code: IKD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070926
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2016

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/26/2016
• Initial Date FDA Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: EXTERNAL PACER 5391, SERIAL NUMBER (B)(4)