MAUDE Adverse Event Report: XOMED MICROFRANCE MFG XOMED® INSTRUMENTS; ELEVATOR, ENT

Model Number 3714383

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2014

Event Type  malfunction  

Event Description

It was reported that a 3mm gorney suction elevator broke intraoperatively during a septoplasty on (b)(6) male, (b)(6).There was no patient impact or injury reported as a result of this event and the status of the patient was reported to be ¿normal.¿.

Manufacturer Narrative

(b)(4).In response to medtronic¿s request for device return, no device was received for evaluation.Method: no testing methods performed.This device is used for therapeutic purposes.

Manufacturer Narrative

The following additional information was received on january 6, 2015¿ ¿ the break did not result in fragments or potential fragments inside the surgical field.¿ no medical intervention was performed or required.¿ the case was successfully completed using another device.The following information was received january 8, 2015¿ ¿ in response to medtronic¿s request for device return, the device was received for evaluation on december 31, 2014 (detailed as follows): the suction tube was broke next to the laser weld, and the deformation at the break point indicates it was bent prior to breaking.The inner stylet was removed and was found severely bent at the edge of the knurl.The breakage appears to be consistent with customer mishandling of the product.(b)(4).

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: XOMED® INSTRUMENTS
• Type of Device: ELEVATOR, ENT
• Manufacturer (Section D): XOMED MICROFRANCE MFG; saint-aubin-le-monial; bourbon-l'archambault 3160 ; FR 3160
• Manufacturer (Section G): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: jacklyn hayman ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9042812769
• MDR Report Key: 4338533
• MDR Text Key: 5204413
• Report Number: 9680837-2014-00111
• Device Sequence Number: 1
• Product Code: KAD
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,company represent
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3714383
• Device Catalogue Number: 3714383
• Device Lot Number: 140501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 00044 YR
• Patient Weight: 84