FDA Adverse Event
Malfunction
Summary report: N
THE HEART LASER CO2 TMR SYSTEM
MDR report key: 217800
·
Received April 2, 1999
Report
- Report Number
- 1287243-1999-00002
- Event Type
- Malfunction
- Date Received
- April 2, 1999
- Date of Event
- March 2, 1999
- Report Date
- March 3, 1999
- Manufacturer
- PLC MEDICAL SYSTEMS, INC.
- Product Code
- MNO
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
ON THE 48TH SHOT, THE LASER FIRED 4 RAPID SHOTS WITHOUT DISARMING. LASER OPERATOR BELIEVES FIRING STOPPED AS A RESULT OF HIM LETTING UP ON THE FOOTSWITCH. ALL SHOTS WENT INTO THE SAME CHANNEL. CHANNEL DID NOT APPEAR DIFFERENT TO SURGEON. PT DOING WELL. NO FIBRILLATION OR ABNORMAL ELECTROCARDIOGRAM EVENTS WERE DETECTED DURING RAPID FIRE. AFTER TESTING ON TONGUE BLADE, THE LASER WAS THEN USED FOR AN ADDITIONAL 3 SHOTS, ALL THESE SHOTS PRODUCED CONFIRMED CHANNELS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THE HEART LASER CO2 TMR SYSTEM | CARDIOVASCULAR SURGICAL LASER | MNO | PLC MEDICAL SYSTEMS, INC. | HEART 08 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Other |