FDA Adverse Event Malfunction Summary report: N

KNIFE

MDR report key: 3123748 · Received May 15, 2013

Report

Report Number: 2523835-2013-00070
Event Type: Malfunction
Date Received: May 15, 2013
Report Date: April 18, 2013
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

NO SAMPLES WERE RETURNED FOR EVALUATION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. BECAUSE A SAMPLE WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED, THE ROOT CAUSE FOR THE DULL KNIFE EXPERIENCED BY THE CUSTOMER CANNOT BE DETERMINED. SOME POTENTIAL CAUSES ARE REUSE, IMPROPER HANDLING, OR CONTACT WITH ANOTHER INSTRUMENT ON THE INSTRUMENT TRAY DURING PROCEDURE SETUP. ALL KNIVES ARE 100% INSPECTED BY TRAINED OPERATORS USING A MINIMUM OF 10X MAGNIFICATION DURING MANUFACTURING. ANY DEFECTS, SUCH AS DAMAGED TIPS AND CUTTING EDGES, ARE REMOVED FROM THE LOT AND SCRAPPED. PENETRATION 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 SURGEON REPORTED THAT DURING MULTIPLE PROCEDURES, SHE NOTICED THAT THE KNIVES WERE NOT AS SHARP AS THEY SHOULD BE. EACH TIME THE ISSUE OCCURRED THE KNIFE WAS EXCHANGED. THERE WAS NO HARM TO THE PATIENTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
215355	KNIFE	MANUAL OPHTHALMIC SURGICAL INSTRUMENT	HNN	ALCON PRECISION DEVICE - SINKING SPRING	8065992445	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1