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

Model Number 2233-005

Device Problem Break (1069)

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

Event Date 11/08/2018

Event Type  malfunction  

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 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
• 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: 8137996
• MDR Text Key: 129597311
• Report Number: 2021898-2018-00550
• Device Sequence Number: 1
• Product Code: GWG
• UDI-Device Identifier: 00613994840240
• UDI-Public: 00613994840240
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2017
• 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