FDA Adverse Event
Malfunction
Summary report: N
AUTO SUTURE AUTOSONIX ULTRA SHEARS SHORT
MDR report key: 736345
·
Received June 24, 2005
Report
- Report Number
- 1219930-2005-00192
- Event Type
- Malfunction
- Date Received
- June 24, 2005
- Date of Event
- May 20, 2005
- Report Date
- May 24, 2005
- Manufacturer
- NORTH HAVEN - USS
- Product Code
- LFL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
6/23/2005 - INITIAL REPORT SENT TO THE FDA.
Description of Event or Problem · 1
THE DEVICE WAS USED DURING A RADIOFREQUENCY ABLATION. REPORTEDLY COMPONENTS FROM THE INSTRUMENT DISENGAGED INTO THE PT'S CAVITY. AT THIS TIME NO ADD'L INFO WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTO SUTURE AUTOSONIX ULTRA SHEARS SHORT | ULTRASONIC HAND INSTRUMENT | LFL | NORTH HAVEN - USS | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |