FDA Adverse Event
Malfunction
Summary report: N
HARMONIC ACE 36CM W ERG HANDLE
MDR report key: 1231195
·
Received November 10, 2008
Report
- Report Number
- 3005075853-2008-02903
- Event Type
- Malfunction
- Date Received
- November 10, 2008
- Date of Event
- October 16, 2008
- Report Date
- October 17, 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
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 11/10/2008. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LIVER LOBE RESECTION PROCEDURE, THE DEVICE'S TISSUE PAD CAME OFF AND IT DID NOT FALL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HARMONIC ACE 36CM W ERG HANDLE | LFL | ETHICON ENDO-SURGERY, LLC | NA | E4LM3U |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | HANDPIECE| GENERATOR |