FDA Adverse Event
Malfunction
Summary report: N
HARMONIC* BLUE HAND PIECE AND BLUE TEST TIP
MDR report key: 3132156
·
Received May 29, 2013
Report
- Report Number
- 3005075853-2013-02589
- Event Type
- Malfunction
- Date Received
- May 29, 2013
- Date of Event
- May 1, 2013
- Report Date
- May 8, 2013
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- LFL
- PMA / PMN Number
- K063192
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS. SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. IMPLANT DATE - UNKNOWN, ASSUMED 1ST DAY OF MONTH ((B)(6) 2013) THAT COMPLAINT WAS REPORTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE O.R. WAS GETTING CHANGE HAND PIECE ERRORS WHEN ATTEMPTING TO USE THEIR HAND PIECES WITH AN UNAPPROVED REPROCESSOR (ASCENT) . THERE WAS NO PATIENT CONSEQUENCE, BUT NO FURTHER INFORMATION CONCERNING EITHER THE PATIENT OR THE CASE. NO DEVICE WILL BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 235684 | HARMONIC* BLUE HAND PIECE AND BLUE TEST TIP | HANDPIECE | LFL | ETHICON ENDO-SURGERY, LLC. | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GENERATOR |