FDA Adverse Event
Malfunction
Summary report: N
KNIFE
MDR report key: 1940513
·
Received December 17, 2010
Report
- Report Number
- 2523835-2010-00147
- Event Type
- Malfunction
- Date Received
- December 17, 2010
- Report Date
- November 19, 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 Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLES HAVE BEEN RECEIVED AND IN-HOUSE EVALUATION IS IN PROGRESS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A SURGEON REPORTED ON MULTIPLE OCCASIONS, BLUNT KNIFE USED DURING PROCEDURE. THE PROCEDURES WERE COMPLETED WITHOUT PATIENT INJURY OR HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KNIFE | MANUAL OPHTHALMIC SURGICAL INSTRUMENT | HNN | ALCON PRECISION DEVICE-SINKING SPRING | 8065992848 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |