FDA Adverse Event Malfunction Summary report: N

CUSTOM PAK

MDR report key: 3802258 · Received March 24, 2014

Report

Report Number: 3002037047-2014-00025
Event Type: Malfunction
Date Received: March 24, 2014
Date of Event: February 24, 2014
Report Date: February 28, 2014
Manufacturer: ALCON - BELGIUM/ ALCON N.V.
Product Code: KYG
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SW
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

NO SAMPLE HAS BEEN RECEIVED FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT WAS REVIEWED. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO A DULL KNIFE WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO THE ACCEPTANCE CRITERIA. BECAUSE A SAMPLE WAS NOT RETURNED AND NO EVIDENCE OF NONCONFORMITY COULD BE FOUND IN THE LOT RECORD REVIEW, THE ROOT CAUSE FOR THE DEFECT "KNIFE WAS SO DULL" REPORTED BY THE CUSTOMER CANNOT BE DETERMINED. SOME POTENTIAL CAUSES ARE REUSE, IMPROPER HANDLING, OR CONTACT WITH ANOTHER INSTRUMENT. ALL KNIVES ARE 100% INSPECTED BY TRAINED OPERATORS USING A MINIUM OF (B)(4) MAGNIFICATION DURING MANUFACTURING. 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 SURGEON REPORTED THAT A KNIFE WAS SO DULL IT WAS IMPOSSIBLE TO PENETRATE THE CORNEA DURING SURGERY. THE KNIFE WAS CHANGED WITH ANOTHER KNIFE BEFORE THE CORNEA WAS PENETRATED WITH NO DELAY TO THE PROCEDURE. THERE WAS NO PT INJURY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
171339	CUSTOM PAK	CONVENIENCE KIT	KYG	ALCON - BELGIUM/ ALCON N.V.	CUSTOM PAK	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1				CLEARCUT HP2 DB SLIT 2.2MM ANG