FDA Adverse Event
Malfunction
Summary report: N
HARMONIC ACE 23 CM
MDR report key: 1112665
·
Received August 11, 2008
Report
- Report Number
- 3005075853-2008-01075
- Event Type
- Malfunction
- Date Received
- August 11, 2008
- Date of Event
- July 22, 2008
- Report Date
- July 24, 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
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
D4; H4, 6: INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A GASTRECTOMY PROCEDURE, THE TISSUE PAD WAS REMOVED FROM THE DEVICE. IT DID NOT FALL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HARMONIC ACE 23 CM | LFL | ETHICON ENDO-SURGERY, LLC | NA | E4L66K |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | HANDPIECE| GENERATOR |