MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY NEUROPEN NEUROENDOSCOPES; ENDOSCOPE, NEUROLOGICAL

Model Number	2120-025
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	05/01/2018
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 there were many black dots on the image when using the video.It was stated there were multiple broken fibers on the device.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported that there was no injury to the patient and the patient's current status was they were doing fine.
Additional Manufacturer Narrative
The returned endoscope produced an image with black dots.It is unknown what caused the reported event.After cleaning the endoscope, the endoscope produced a clear image.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
All endoscope devices are 100% image tested at the time of manufacture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NEUROPEN NEUROENDOSCOPES
• Common Device Name: ENDOSCOPE, NEUROLOGICAL
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7500272
• Report Number: 2021898-2018-00244
• Device Sequence Number: 2211050
• Product Code: GWG
• UDI-Device Identifier: 00613994840233
• UDI-Public: 00613994840233
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K003914
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/13/2018

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: 07/31/2019
• Device Model Number: 2120-025
• Device Catalogue Number: 2120-025
• Device Lot Number: E41817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2018
• Supplement Date Received by Manufacturer: 05/10/2018; 05/24/2018; 06/13/2018
• Initial Report FDA Received Date: 05/09/2018
• Supplement Report FDA Received Date: 05/22/2018; 05/30/2018; 06/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1