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

Model Number CUSTOM PAK

Device Problems Dull, Blunt (2407); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A surgeon reported that knives are repeatedly unsharp with the tip of the knives already defective when the surgeon takes them out from the safety pad.There is no procedure or pt involvement.Add'l info has been requested.

Manufacturer Narrative

A sample is available that has not yet been received by manufacturing for eval.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 info 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.Add'l info has been 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 s freeway; r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 4507667
• MDR Text Key: 5529841
• Report Number: 3002037047-2015-00038
• 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: Physician
• Type of Report: Initial
• Report Date: 01/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2015
• 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: 01/19/2015
• 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