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

Model Number	2233-005
Medical Device Problem Codes	Break (1069); Poor Quality Image (1408)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that when the scope was opened, it was bent at one part.When it was set up and trying to focus, the scope was showing a weird image that must have been the inside of the channel scope and not actually the suture packet they were trying to focus on to set it up.
Additional Manufacturer Narrative
The channel neuroendoscope had a break in the tubing.Therefore, the functionality testing could not be performed due to the damaged.It is not known how or when this damage occurred.The instructions for use cautions, ¿handle channel neuroendoscope with extreme care.Do not bend or squeeze the reinforced fiber optics shaft; this could result in fracture of the fiber optic bundle.Damage to the fiber optic bundle with result in decreased illumination in the field of visualization, or loss of image or distortion of the image.¿ if information is provided in the future, a supplemental report will be issued.

• 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: 8729342
• Report Number: 2021898-2019-00252
• Device Sequence Number: 13958599
• Product Code: GWG
• UDI-Device Identifier: 00613994840240
• UDI-Public: 00613994840240
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2019

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: 11/30/2019
• Device Model Number: 2233-005
• Device Catalogue Number: 2233-005
• Device Lot Number: E41661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 07/16/2019
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 08/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1