MAUDE Adverse Event Report: COVIDIEN LP ELECTRODE EXTENSION; ES ACCESSORY

Model Number E1502

Device Problems Crack (1135); Sparking (2595); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2015

Event Type  malfunction  

Manufacturer Narrative

Covidien reference#: (b)(4).Date of initial report: 11/3/2015.The incident device has been received and is under evaluation.When the device evaluation is complete a follow-up report will be submitted.

Event Description

The customer reported that during use of the device, sparks were seen.A little crack was noted on the electrode extension.A new extension was used.There was no patient injury.Covidien's initial evaluation of the incident device found the insulation was scratched down to bare metal.The extension failed hipot testing.

Manufacturer Narrative

(b)(4).Evaluation of the incident electrode extension confirmed the insulation was compromised resulting in the device failing hipot testing.There was mechanical damage along the entire shaft of the insulation in the form of nicks and scrapes, with concentrated damage in the areas that failed hipot testing.The instructions for use warn the user to inspect the extension frequently (before and after each use) for cracks, nicks, cuts, dents or depressions, which may decrease the insulation effectiveness and may result in burns to the surgeon or patient.

• Brand Name: ELECTRODE EXTENSION
• Type of Device: ES ACCESSORY
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder CO 80301
• Manufacturer Contact: sharon murphy ; 5920 longbow drive; boulder, CO 80301 ; 2034925267
• MDR Report Key: 5197774
• MDR Text Key: 30547384
• Report Number: 1717344-2015-00778
• Device Sequence Number: 1
• Product Code: BWA
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E1502
• Device Catalogue Number: E1502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1