MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NIM® EMG - ENDOTRACHEAL TUBE; STIMULATOR, NERVE

Model Number	8229307
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product evaluation: when the emg tube was received, the electrode wires were not bound with the white tape as manufactured and the red / white electrode was missing, which indicates handling of the device.A syringe was used to inject the cuff with 20cc of air and there was no ¿visually¿ detectable leak after 1 minute; it was not until the device was submerged in water that a leak was observed (not at the white plug but in the cuff).To quantify the leak further, 20cc of air was injected into the cuff and after 1 minute approximately 15cc of air was removed (loss of 5cc per minute).There was a v-shaped puncture on the proximal side of the cuff measuring 0.015¿ wide which would have resulted in the reported event.The shape of the damage was consistent with an external to internal puncture.The puncture did not align with an electrode wire and the electrode wires were within their respective lumens.The information most likely indicates the puncture was the result of inadvertent mishandling, such as an electrode needle (red / white or green) puncturing the cuff.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During set-up for a thyroidectomy/parathyroidectomy procedure, the physician tested the emg tube for patency.After inflating the cuff the physician found that the "cuff of the tube (the white plug) was leaking"; the inflation assembly.A new device was used for the procedure.There was no patient impact.

• Brand Name: NIM® EMG - ENDOTRACHEAL TUBE
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• MDR Report Key: 6776700
• Report Number: 1045254-2017-00274
• Device Sequence Number: 880907
• Product Code: ETN
• UDI-Device Identifier: 00643169358713
• UDI-Public: 00643169358713
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K925640
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/13/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/13/2020
• Device Model Number: 8229307
• Device Catalogue Number: 8229307
• Device Lot Number: 0211444221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2017
• Initial Report FDA Received Date: 08/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR