FDA Adverse Event
Malfunction
Summary report: N
KNIFE
MDR report key: 1910033
·
Received November 10, 2010
Report
- Report Number
- 2523835-2010-00126
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- October 7, 2010
- Report Date
- October 11, 2010
- 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 Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
THE SURGEON REPORTED: BLUNT KNIVES. TRIED TWO KNIVES FROM THE BOX AND FOUND TO BE BLUNT. NO PT IMPACT WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KNIFE | MANUAL OPHTHALMIC SURGICAL INSTRUMENT | HNN | ALCON PRECISION DEVICE - SINKING SPRING | 8065982465 | 805204M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |