FDA Adverse Event
Malfunction
Summary report: N
ULTRACISION HARMONIC ACE
MDR report key: 2870334
·
Received December 12, 2012
Report
- Report Number
- 3005075853-2012-05636
- Event Type
- Malfunction
- Date Received
- December 12, 2012
- Date of Event
- October 12, 2012
- Report Date
- October 12, 2012
- 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
(B)(4). THERE WERE SIX STERILE DEVICES INSIDE OF THE SALES UNIT BOX RECEIVED. ONE OF THE DEVICES WAS RECEIVED HAD A SPOT IN THE TYVEK, WHICH MADE THE ETHICON LOGO HARD TO READ. NO CONCLUSION CAN BE REACHED ON HOW THE TYVEK WAS SPOT. EACH DEVICE IS VISUALLY INSPECTED DURING THE PACKAGING PROCESS AND DAMAGE OF THIS MAGNITUDE WOULD HAVE BEEN DETECTED.
Description of Event or Problem · 1
AFFILIATE'S RECEIVING FACILITY RECEIVED THE PRODUCT AND DURING INCOMING/LABELING OPERATION FOUND THE FOLLOWING DEFECT. DETAILS OF THE DEFECT IS: UNREADABLE PRINTED LABEL (POOR PRINT / OTHERS).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRACISION HARMONIC ACE | INSTRUMENT, ULTRASONIC SURGICAL | LFL | ETHICON ENDO-SURGERY, LLC. | UNK | J92473 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GENERATOR AND HANDPIECE |