MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CHANNELSCOPE NEUROENDOSCOPE 30K; 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	07/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
It was reported the glass on the neuroendoscope cracked when opened.The product was replaced.
Additional Manufacturer Narrative
The returned endoscope could not be tested due to a kink in the guidewire, indicating that the image fiber (glass) that runs through the guidewire is broken.It is unknown how or when this damage occurred.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CHANNELSCOPE NEUROENDOSCOPE 30K
• Common Device Name: ENDOSCOPE, NEUROLOGICAL
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6904186
• Report Number: 2021898-2017-00496
• Device Sequence Number: 1239624
• Product Code: GWG
• UDI-Device Identifier: 00613994840240
• UDI-Public: 00613994840240
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K002572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2017

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: 07/31/2018
• Device Model Number: 2233-005
• Device Catalogue Number: 2233-005
• Device Lot Number: E16665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2017
• Supplement Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 09/29/2017
• Supplement Report FDA Received Date: 11/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1