MAUDE Adverse Event Report: ALCON - BELGIUM/ ALCON NV CUSTOM PAK; CONVENIENCE KIT

Model Number CUSTOM PAK

Device Problem Dull, Blunt (2407)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A pharmacist reported that a knife was noted to be blunt prior to surgery.There was no pt involvement.Add'l info has been requested.

Manufacturer Narrative

No sample was returned for the report of a blunt, defective knife.The final customer lot was identified as 985431m, mfg on 10/29/2014.For this final lot, one component knife lot, 981769m mfg in september 2014, was used to make up the final lot.A device history record review for each of the knife lots was conducted.No anomaly was found during the device history record reviews.The prod was released based on the mfr's acceptance criteria.No add'l investigation is required based on device history review.A complaint history review indicates no add'l complaints were associated with the knife lots.The root cause for the defect experienced by the customer cannot be determined.All knives are 100% inspected by trained operators using a minimum of 10x magnification during mfg.Nonconformances, such as a damaged tip or cutting edge described in the complaint, are removed from the lot and scrapped.Functional testing is performed and monitored during the finishing process to ensure the sharpness of the prod.(b)(4).

• Brand Name: CUSTOM PAK
• Type of Device: CONVENIENCE KIT
• Manufacturer (Section D): ALCON - BELGIUM/ ALCON NV; medialaan 36; vilvoorde B-180 0; BE B-1800
• Manufacturer (Section G): ALCON - BELGIUM/ ALCON NV; 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: 4534882
• MDR Text Key: 5520332
• Report Number: 3002037047-2015-00047
• Device Sequence Number: 1
• Product Code: KYG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: CUSTOM PAK
• Device Catalogue Number: CUSTOM PAK
• Device Lot Number: 411138
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2015
• Initial Date FDA Received: 02/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• 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