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

Model Number 2120-025

Device Problems Break (1069); Poor Quality Image (1408)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported that there was no injury to the patient and the patient's current status was they were doing fine.

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.

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
• Type of Device: ENDOSCOPE, NEUROLOGICAL
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 7500272
• MDR Text Key: 107822809
• Report Number: 2021898-2018-00244
• Device Sequence Number: 1
• Product Code: GWG
• UDI-Device Identifier: 00613994840233
• UDI-Public: 00613994840233
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1