MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CHANNEL NEUROENDOSCOPE, 30K, 2MM, SHORT, HIGH RESOLUTION; ENDOSCOPE, NEUROLOGICAL

Model Number	2233-005
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The channel neuroendoscope was returned with a burnt-out illumination connector end.Therefore, the functionality testing could not be performed due to the damaged condition of the illumination connector end.It is not known how or when this damage occurred.However, it could have been the result of the illumination connector being connected to an incompatible light cable.The ifu cautions that, ¿the endoscope should only be connected to a compatible light cable.Other light cables could overheat and damage the illumination connector on the endoscope.¿ it further cautions that, ¿do not connect the endoscope directly to the light source or the illumination connector may overheat.¿ if information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the endoscope failed upon use.One end of the endoscope was burnt.

• Brand Name: CHANNEL NEUROENDOSCOPE, 30K, 2MM, SHORT, HIGH RESOLUTION
• Common Device Name: ENDOSCOPE, NEUROLOGICAL
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8137996
• Report Number: 2021898-2018-00550
• Device Sequence Number: 16616313
• Product Code: GWG
• UDI-Device Identifier: 00613994840240
• UDI-Public: 00613994840240
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K002572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2018

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: 09/30/2019
• Device Model Number: 2233-005
• Device Catalogue Number: 2233-005
• Device Lot Number: E39190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 12/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1