FDA Adverse Event
Other
Summary report: N
KARL STORZ
MDR report key: 2897599
·
Received November 29, 2012
Report
- Report Number
- 9610617-2012-00043
- Event Type
- Other
- Date Received
- November 29, 2012
- Date of Event
- October 13, 2012
- Report Date
- November 28, 2012
- Manufacturer
- KARL STORZ GMBH & CO. KG
- Product Code
- CCW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
HOSPITAL IS NOT RELEASING INSTRUMENT.
Description of Event or Problem · 1
ALLEGEDLY, DURING AN INTUBATION, THE TOP OF A LARYNGOSCOPE ASSEMBLY SEPARATED FROM THE BODY OF THE HANDLE CAUSING A JERKING MOTION BY USER WITH THE RESULT THAT THE BLADE ATTACHED TO THE TOP OF THE HANDLE MADE CONTACT WITH PT'S UPPER GUMS CAUSING MINOR BLEEDING. NO MEDICAL ATTENTION WAS REQUIRED; INTUBATION WAS COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KARL STORZ | LARYNGOSCOPE HANDLE | CCW | KARL STORZ GMBH & CO. KG | 8546 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |