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 extension cable was returned to the distributor for analysis.No information was provided as to the problem experienced.The cable was received with both positive and negative connectors broken off the cable, and both positive and negative stress reliefs pulled from the connectors.Testing of both positive and negative connections determined both to be open due to damage.The cause of the failure could not be determined.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

This extension cable was returned to the distributor without information.

• 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: 5567285
• MDR Text Key: 42374847
• Report Number: 1035166-2016-00070
• 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
• Reporter Occupation: Other
• 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: Other Health Care Professional
• Device Model Number: 53912
• Device Catalogue Number: 53912
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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