FDA Adverse Event
Malfunction
Summary report: N
MINI DIAMOND FORCEPS TIP, 1.3MM
MDR report key: 1375343
·
Received February 20, 2009
Report
- Report Number
- 3003398873-2009-00001
- Event Type
- Malfunction
- Date Received
- February 20, 2009
- Date of Event
- January 23, 2009
- Report Date
- January 23, 2009
- Manufacturer
- ALCON GRIESHABER AG
- Product Code
- HNR
- PMA / PMN Number
- K911808
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE TIP FROM THE FORCEPS BROKE OFF IN A PT'S EYE DURING THE PROCEDURE. CURRENT PT STATUS IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MINI DIAMOND FORCEPS TIP, 1.3MM | FORCEPS, OPHTHALMIC/UNIT, PHACOFRAGMENTATION | HNR | ALCON GRIESHABER AG | 712.12.00 | F67877 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |