FDA Adverse Event
Malfunction
Summary report: N
KNIFE
MDR report key: 3772419
·
Received December 18, 2013
Report
- Report Number
- 2523835-2013-00189
- Event Type
- Malfunction
- Date Received
- December 18, 2013
- Report Date
- December 9, 2013
- Manufacturer
- ALCON MANUFACTURING, LTD.
- Product Code
- HNN
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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 ADD'L REPORTABLE INFO BECOMES AVAILABLE. ALL KNIVES ARE 100% INSPECTED BY TRAINED OPERATORS USING A MINIMUM OF (B)(4) MAGNIFICATION DURING MFG. ANY DEFECTS, SUCH AS DAMAGED TIPS AND CUTTING EDGES, ARE REMOVED FROM THE LOT AND SCRAPPED. SHARPNESS TESTING IS PERFORMED AND MONITORED DURING THE FINISHING PROCESS TO ENSURE THE SHARPNESS OF THE PRODUCT. (B)(4).
Description of Event or Problem · 1
A CUSTOMER REPORTED A DULL KNIFE DURING SURGERY. THERE WAS NO PATIENT HARM REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 663935 | KNIFE | MANUAL OPHTHALMIC SURGICAL INSTRUMENT | HNN | ALCON MANUFACTURING, LTD. | 8065982465 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |