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

Model Number 53912

Device Problem Break (1069)

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

Event Date 12/28/2016

Event Type  malfunction  

Manufacturer Narrative

There are six (6) complaints related to this extension cable, from the same end user; it was reported there was no patient involvement.A review of the device history records could not be performed as the lot number of these cables are unknown.Per analysis, six (6) extension cables were returned from the customer.There were no other accessories, and no visible blood was found anywhere on any of the extension cables.(b)(4): the cable was returned with the negative connector separated from the rest of the cable.The negative connector broke at the exposed wires adjacent to the solder joint.The negative connector was separated from the rest of the cable.The failure occurred on the negative connector at the exposed portion of wire adjacent to the solder joint.The dimensional and functional observations that could be obtained are within manufacturing specifications.(b)(4): the cable was returned with both connectors attached to the cable.It was found that the wire connected to the positive connector had fractured inside of the strain relief.The positive connector broke at the exposed wires adjacent to the solder joint.The negative connector was separated from the rest of the cable.The failure occurred on the positive connector at the exposed portion of wire adjacent to the solder joint.The dimensional and functional observations that could be obtained are within manufacturing specifications.(b)(4): the cable was returned with both connectors attached to the cable.The visual, dimensional, and functional observations are all within manufacturing specifications.(b)(4): the cable was returned with both connectors attached to the cable.It was found that the wires connected to both the positive and negative connectors had fractured inside of the strain relief.Both connector broke at the exposed wires adjacent to the solder joint.The failure occurred on both connectors at the exposed portion of wire adjacent to the solder joint.The dimensional observations obtained are within manufacturing specifications.(b)(4): the cable was returned with both connectors attached to the cable.It was found that the wires connected to the negative connector were fractured inside of the strain relief.The negative connector broke at the exposed wire adjacent to the solder joint.The negative connector was separated from the rest of the cable.The failure occurred on the negative connector at the exposed portion of wire adjacent to the solder joint.The dimensional and functional observations that could be obtained are within manufacturing specifications.(b)(4): the cable was returned with both connectors attached to the cable.Adhesive/ tape residue was found on the strain reliefs.The cable strands were separated all the way to the silicone strain relief for the plug connector.The silicone strain relief was bunched up because of the cable separation.It was found that the negative connector had broken strands but was still attached.The failure occurred on the negative connector at the exposed portion of wire adjacent to the solder joint.The negative connector was not completely detached but had multiple broken strands causing the continuity to be open.The dimensional and functional observations that could be obtained are within manufacturing specifications.Based on these investigation's a capa has been opened to address this failure.Oscor will continue to monitor this device for complaint trends and risk.Per cable inspection procedure during in process inspection, the cable is inspected 100% for continuity.During final inspection, each strand of the cable is checked for the correct colored part, overall length of the cable, cable checked for damage and insulation voids, verification that the silicone strain relief extends at least for a length of 2 cm outside the female connector, checked that the silicone strain relief fits the wire snugly, checks for strain relieves for damage and gaps, a pull test is done on each connector and pin, and the cable is inspected again for continuity.The instructions for use (ifu) informs the user: for reusable cables only: the cables can be re-sterilized by oscor eto gas sterilization a maximum of two times.The directions for use inform the user to: first attach the proximal connector(s) to a pacemaker/analyzer or another extension cable while observing polarity indicated by the color.Then attach the distal connector(s) to the temporary lead connector or to another extension cable, again observing polarity by the color.The detachment of the connection should be done in the reverse order.Precautions include: 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.Extension cables are not intended for use with apnea monitors.

Event Description

It was reported the 53912 ipg adapter is not robust enough for normal use.The adapter was replaced and is expected to be returned; customer reported six devices will be returned for analysis.No patient complications have been reported as a result of this event.

• Brand Name: MEDTRONIC REUSABLE EXTENSION CABLE
• Type of Device: CABLE, ELECTRODE
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• Manufacturer (Section G): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• Manufacturer Contact: dorit segal ; 3816 desoto blvd.; palm harbor, FL 34683-1816 ; 7279372511
• MDR Report Key: 6605774
• MDR Text Key: 76592245
• Report Number: 1035166-2017-00043
• Device Sequence Number: 1
• Product Code: IKD
• UDI-Device Identifier: 00885672101930
• UDI-Public: 00885672101930
• 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,health profession
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 53912
• Device Catalogue Number: 53912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2017
• 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