| Brand Name | GlideScope Core 10-Inch Monitor |
| Common Device Name | LARYNGOSCOPE, RIGID |
| Manufacturer (Section D) |
| Verathon Medical ULC |
| 2227 douglas road |
| burnaby, british columbia V5C 5 A9 |
| CA V5C 5A9 |
|
| Manufacturer (Section G) |
| Verathon Medical ULC |
| 2227 douglas road |
|
| burnaby, british columbia V5C 5 A9 |
|
CA
V5C 5A9
|
|
| Manufacturer Contact |
|
corey
kasbohm
|
| 20001 n creek pkwy |
| bothell, WA 98011--821
|
|
+1(425)629-5760
|
|
| MDR Report Key | 50776916 |
| Report Number | 9615393-2026-00137 |
| Device Sequence Number | 10708065 |
| Product Code |
CCW
|
| UDI-Device Identifier | 00879123006509 |
| UDI-Public | 00879123006509 |
| Combination Product (Y/N) | N |
| Initial Reporter Country | CA |
| PMA/510(K) Number | Exempt |
| Number of Events Summarized | 1 |
| Summary Report (Y/N) | N |
| Reporter Type |
Manufacturer
|
| Report Source |
Foreign,User Facility |
| Initial Reporter Occupation |
Other Health Care Professional
|
| Type of Report
| Initial |
| Report Date (Section B) |
09/15/2026 |
| 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 Model Number | 0570-0376 |
| Device Catalogue Number | 0270-0996 |
| Device Lot Number | N/A |
| Was Device Available for Evaluation? |
No
|
| Is the Reporter a Health Professional? |
Yes
|
| Type of Report(Section G) | Thirty-Day |
| Initial Date Received by Manufacturer | 08/19/2026 |
| Initial Report FDA Received Date | 09/15/2026 |
| Was Device Evaluated by Manufacturer? (Y/N) |
No
|
| Is the Device Labeled for Single Use? (Y/N) |
No
|
Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N) |
No
|
| Usage of Device |
Reuse
|
| Patient Sequence Number | 1 |
| Patient Sex | Unknown |
|
|