MAUDE Adverse Event Report: COVDIEN LP EDGE INSUL. COATED BLADE; ES ACCESSORY, NON-STERILE

Model Number E1455NSB

Device Problems Detachment Of Device Component (1104); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Code Available (3191)

Event Date 10/08/2014

Event Type  Injury  

Event Description

The customer reported that during the procedure when the doctor cleaned the electrode tip, the clear insulation sleeve came off.The piece was not located and may have fallen into the patient cavity.

Manufacturer Narrative

(b)(4).The return of the incident sample has been requested.To date, it has not been received for evaluation.Additional questions in regard to the incident have been asked.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.

• Brand Name: EDGE INSUL. COATED BLADE
• Type of Device: ES ACCESSORY, NON-STERILE
• Manufacturer (Section D): COVDIEN LP; 5920 longbow drive; boulder CO 80301
• Manufacturer Contact: sharon murphy ; 5920 longbow drive; boulder, CO 80301 ; 2034925267
• MDR Report Key: 4242901
• MDR Text Key: 5015857
• Report Number: 1717344-2014-00913
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: E1455NSB
• Device Catalogue Number: E1455NSB
• Device Lot Number: 41670099X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2014
• 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
• Patient Outcome(s): Other
• Patient Age: 64 YR