FDA Adverse Event
Malfunction
Summary report: N
HARMONIC ACE
MDR report key: 2171532
·
Received July 20, 2011
Report
- Report Number
- 2171532
- Event Type
- Malfunction
- Date Received
- July 20, 2011
- Date of Event
- July 7, 2011
- Report Date
- July 20, 2011
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- LFL
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CO, US
Narratives
Description of Event or Problem · 1
OPERATING ROOM STAFF REPORTS THAT WHILE SURGEON UTILIZING THE ACE45E SHEAR IN A LAPBAND PLACEMENT PROCEDURE HE NOTICED SOMETHING WHITE ON THE TIP OF THE DEVICE. INITIALLY HE THOUGHT IT WAS LINT, REMOVED DEVICE FROM PATIENT SO SURGICAL TECH COULD CLEAN THE TIP AND NOTICED THAT THE WHITE TIP WAS ACTUALLY LOOSE AND WAS ABOUT TO COME OFF. DEVICE IMMEDIATELY REMOVED FROM SERVICE, DEVICE STILL INTACT BUT TIP LOOSE AND UNABLE TO BE USED FOR REMAINDER OF CASE. NEW DEVICE OBTAINED, NO INJURY TO PATIENT, JUST DELAY IN TROUBLESHOOTING CONCERN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HARMONIC ACE | INSTRUMENT, ULTRASONIC SURGICAL, CURVED SHEARS | LFL | ETHICON ENDO-SURGERY, INC. | ACE45E | H43GIG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |