FDA Adverse Event
Malfunction
Summary report: N
HI-LO TRACHEAL TUBE, 8.0MM
MDR report key: 89431
·
Received May 2, 1997
Report
- Report Number
- 9681384-1997-00044
- Event Type
- Malfunction
- Date Received
- May 2, 1997
- Date of Event
- March 26, 1997
- Report Date
- May 1, 1997
- Manufacturer
- MALLINCKRODT MEDICAL, INC.
- Product Code
- BTR
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
"TUBE BURNED SEVERELY IN LASER SURGERY - MELTED THE END OFF COMPLETELY." PROCEDURE WAS FOR REMOVING A GRANULOMA ON POST LUNG TRANSPLANT PT. - VENTILATING WITH MEDICAL AIR. USED A FLEXIBLE ENDOSCOPE AND LASER, NO INDICATION THAT SAYS HOW FAR INTO THE PROCEDURE THIS OCCURRED. FIELD OF VIEW WENT BLACK OR SAW A FLASH AND THEN BLACK. FLUSHED WITH AN UNRECORDED AMOUNT OF SALINE SOLUTION AFTER IMMEDIATE REMOVAL OF LASER AND SCOPE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HI-LO TRACHEAL TUBE, 8.0MM | ENDOTRACHEAL TUBE, CUFFED, 8.0MM | BTR | MALLINCKRODT MEDICAL, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Life Threatening| R | FLEXIBLE ENDOSCOPE & LEXUS 60 NDAG LASER |