FDA Adverse Event
Malfunction
Summary report: N
HARMONIC ACE 36 CM
MDR report key: 1211898
·
Received October 23, 2008
Report
- Report Number
- 3005075853-2008-02544
- Event Type
- Malfunction
- Date Received
- October 23, 2008
- Date of Event
- September 11, 2008
- Report Date
- September 15, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- LFL
- PMA / PMN Number
- K042777
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAPAROSCOPIC LEFT HEMI COLECTOMY PROCEDURE, THE TRIGGER MECHANISM OF THE DEVICE WAS NOT OPERATING EFFECTIVELY; THE 'CLICK' OF THE DEVICE WAS OCCURRING ONLY WHEN THE TRIGGER WAS DEPRESSED VERY FIRMLY. THIS CAUSED LOSS OF AN EFFECTIVE GRIP MECHANISM WHEN GRASPING TISSUE AND REDUCED HEMOSTASIS. UNK HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HARMONIC ACE 36 CM | LFL | ETHICON ENDO-SURGERY, LLC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GENERATOR| HANDPIECE |