FDA Adverse Event
Malfunction
Summary report: N
KNIFE
MDR report key: 1220414
·
Received October 31, 2008
Report
- Report Number
- 1610287-2008-00042
- Event Type
- Malfunction
- Date Received
- October 31, 2008
- Report Date
- October 2, 2008
- Manufacturer
- ALCON PRECISION DEVICE - SINKING SPRING
- Product Code
- HNN
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 ADD'L REPORTABLE INFO BECOMES AVAILABLE. THIS REPORT WAS MAILED TO FDA ON: 10/31/2008.
Description of Event or Problem · 1
FACILITY REPORTED THAT THE KNIFE IN THE CUSTOM PACK CUTS JAGGED. ADDITIONAL INFORMATION RECEIVED ON 10/09/2008: REPORTS THAT THE PATIENT OUTCOME IS GOOD AND NO VISUAL DISTURBANCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KNIFE | MANUAL OPHTHALMIC SURGICAL INSTRUMENT | HNN | ALCON PRECISION DEVICE - SINKING SPRING | 8065982963 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |