FDA Adverse Event
Malfunction
Summary report: N
HARMONIC SCALPEL** FOOTSWITCH
MDR report key: 2871352
·
Received December 13, 2012
Report
- Report Number
- 3005075853-2012-05662
- Event Type
- Malfunction
- Date Received
- December 13, 2012
- Date of Event
- November 7, 2012
- Report Date
- November 7, 2012
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- LFL
- PMA / PMN Number
- K002906
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). AFTER REVIEWING THE PHOTOGRAPHS AND THE INFORMATION RECEIVED, THE BARCODE LABEL WITH IDENTIFICATION WAS PRESENT ON THE BOX. THE MULTI-LINGUAL LABEL WAS MISSING.
Description of Event or Problem · 1
IT WAS REPORTED THAT AT THE INCOMING INSPECTION FACILITY FOR AN INTERNATIONAL AFFILAITE, AT THE INCOMING/LABELING OPERATION, FOUND THE FOLLOWING DEFECT. DETAIL OF THE DEFECT IS NO LABEL. (LABEL ON POUCH ILLEGIBLE INCORRECT OR LETTERS/NUMBERS MISSING. (INCLUDES BARCODE ERROR). AT DISTRIBUTION CENTER, NOT A HOSPITAL. THE FOOTWITCH AND PACKAGING WAS NOT RETURNED, ONLY A PHOTOGRAPH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HARMONIC SCALPEL** FOOTSWITCH | INSTRUMENT, ULTRASONIC SURGICAL | LFL | ETHICON ENDO-SURGERY, LLC. | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |