| Brand Name | GLIDESCOPE CORE 15-INCH FHD 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 98011-8218
|
|
4256295760
|
|
| MDR Report Key | 25815072 |
| Report Number | 9615393-2026-00102 |
| Device Sequence Number | 18800813 |
| Product Code |
CCW
|
| UDI-Device Identifier | 00879123008596 |
| UDI-Public | (01)00879123008596(11)250901 |
| Combination Product (Y/N) | N |
| Initial Reporter State | GA |
| Initial Reporter Country | US |
| PMA/510(K) Number | EXEMPT |
| Number of Events Summarized | 1 |
| Summary Report (Y/N) | N |
| Serviced by Third Party (Y/N) | Unknown |
| Reporter Type |
Manufacturer
|
| Report Source |
Health Professional,User Facility,Company Representative |
| Initial Reporter Occupation |
Biomedical Engineer
|
| Type of Report
| Initial |
| Report Date (Section B) |
07/14/2026 |
| 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 | 0570-0437 |
| Device Catalogue Number | 0270-1033-FHD |
| Device Lot Number | N/A |
| Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
| Date Returned to Manufacturer | 07/02/2026 |
| Is the Reporter a Health Professional? |
Yes
|
| Type of Report(Section G) | Thirty-Day |
| Initial Date Received by Manufacturer | 06/22/2026 |
| Initial Report FDA Received Date | 07/14/2026 |
| Was Device Evaluated by Manufacturer? (Y/N) |
Yes
|
| Date Device Manufactured | 09/01/2025 |
| 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 |