MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-06 for CHANNEL NEUROENDOSCOPE, 30K, 2MM, SHORT, HIGH RESOLUTION 2233-005 manufactured by Medtronic Neurosurgery.
[129597311]
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.
Patient Sequence No: 1, Text Type: N, H10
[129597312]
It was reported that the endoscope failed upon use. One end of the endoscope was burnt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021898-2018-00550 |
| MDR Report Key | 8137996 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-06 |
| Date of Report | 2018-12-06 |
| Date of Event | 2018-11-08 |
| Date Mfgr Received | 2018-11-08 |
| Device Manufacturer Date | 2017-10-12 |
| Date Added to Maude | 2018-12-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STACY RUEMPING |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635260594 |
| Manufacturer G1 | MEDTRONIC NEUROSURGERY |
| Manufacturer Street | 125 CREMONA DRIVE |
| Manufacturer City | GOLETA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93117 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHANNEL NEUROENDOSCOPE, 30K, 2MM, SHORT, HIGH RESOLUTION |
| Generic Name | ENDOSCOPE, NEUROLOGICAL |
| Product Code | GWG |
| Date Received | 2018-12-06 |
| Returned To Mfg | 2018-11-28 |
| Model Number | 2233-005 |
| Catalog Number | 2233-005 |
| Lot Number | E39190 |
| Device Expiration Date | 2019-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROSURGERY |
| Manufacturer Address | 125 CREMONA DRIVE GOLETA CA 93117 US 93117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-06 |