MAUDE Adverse Event Report: ALCON - BELGIUM / ALCON N.V. CUSTOM PAK; CONVENIENCE KIT

Model Number CUSTOM PAK

Device Problems Bent (1059); Dull, Blunt (2407)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2014

Event Type  malfunction  

Event Description

A surgeon reported that knives were not sharp during surgeries.There was no patient impact experienced.Additional information has been requested.Additional information was received, whereby the tips of the blunt knives were also bent.This is one of two reports from this facility.

Manufacturer Narrative

A sample is available that has not yet been received by manufacturing for evaluation.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.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.Sharpness testing is performed and monitored during the finishing process to ensure the sharpness of the product.Additional information was requested.(b)(4).

• Brand Name: CUSTOM PAK
• Type of Device: CONVENIENCE KIT
• Manufacturer (Section D): ALCON - BELGIUM / ALCON N.V.; medialaan 36; vilvoorde B-180 0; BE B-1800
• Manufacturer (Section G): ALCON - BELGIUM / ALCON N.V.; medialaan 36; vilvoorde B-18 00; BE B-1800
• Manufacturer Contact: janet moran ; 6201 south freeway, r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 4156535
• MDR Text Key: 17292597
• Report Number: 3002037047-2014-00129
• Device Sequence Number: 1
• Product Code: KYG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CUSTOM PAK
• Device Catalogue Number: CUSTOM PAK
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CLEARCUT HP2 DB SLIT 2.2MM ANG