FDA Adverse Event
Injury
Summary report: N
GREENLINE FIBER OPTIC "D" MACINTOSH #4 BLADE
MDR report key: 1812590
·
Received August 16, 2010
Report
- Report Number
- 1036445-2010-00142
- Event Type
- Injury
- Date Received
- August 16, 2010
- Date of Event
- July 7, 2010
- Report Date
- August 13, 2010
- Manufacturer
- MEDICAL DEVICES (PVT) LTD
- Product Code
- CAL
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
ONE OF CRNAS INDUCED A PT FOR A GETA, USING A GREENLINE/D MAC #4 BLADE, ATTEMPTED A DIRECT LARYNGOSCOPY. DURING THE LARYNGOSCOPY WITH A SUBSEQUENT GRADE I VIEW OF THE GLOTTIC OPENING AND CORDS. BEFORE INTUBATION COULD BE ACCOMPLISHED, THE GREENLINE BLADE FRACTURED AT THE CONNECTION WITH THE LARYNGOSCOPE HANDLE AND SEPARATED. THE FRACTURED BLADE EDGE LACERATED THE PT'S LIP. IT WAS CONFIRMED THAT THE PIECE WHICH HAD BROKEN OFF WAS RECOVERED AND NOT IN PT'S OROPHARYNX OR OTHERWISE WITHIN THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GREENLINE FIBER OPTIC "D" MACINTOSH #4 BLADE | CAL | MEDICAL DEVICES (PVT) LTD | 5-5332-04 | 02F |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |