MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-09-29 for CHANNELSCOPE NEUROENDOSCOPE 30K 2233-005 manufactured by Medtronic Neurosurgery.
[87799752]
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.
Patient Sequence No: 1, Text Type: N, H10
[87799753]
It was reported the glass on the neuroendoscope cracked when opened. The product was replaced.
Patient Sequence No: 1, Text Type: D, B5
[95169793]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021898-2017-00496 |
| MDR Report Key | 6904186 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-09-29 |
| Date of Report | 2017-11-20 |
| Date of Event | 2017-07-21 |
| Date Mfgr Received | 2017-10-30 |
| Device Manufacturer Date | 2016-09-14 |
| Date Added to Maude | 2017-09-29 |
| 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 |
| 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 | CHANNELSCOPE NEUROENDOSCOPE 30K |
| Generic Name | ENDOSCOPE, NEUROLOGICAL |
| Product Code | GWG |
| Date Received | 2017-09-29 |
| Returned To Mfg | 2017-10-03 |
| Model Number | 2233-005 |
| Catalog Number | 2233-005 |
| Lot Number | E16665 |
| Device Expiration Date | 2018-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2017-09-29 |