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

Model Number CUSTOM PAK

Device Problem Dull, Blunt (2407)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A healthcare professional reported that the knives were noted to be blunt during two separate surgeries.The procedure was completed with the same knife.No pt impact was experienced.Add'l info has been requested.

Manufacturer Narrative

No sample was returned for eval.The final customer lot was unk, but may have been from lot 980337m or 982094m, both mfg in september 2014.A device history record review for the lots were conducted.The device history record reviews had no abnormalities and did not point to a root cause because the lots were released based on the mfr's acceptance criteria.No add'l investigation is required based on device history review.A complaint history review indicates one add'l complaint was associated with these lots.The root cause for the customer complaint issue cannot be determined.All knives are 100% visually inspected and tested for penetration during mfg.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No add'l action is required at this time.(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: 4551455
• MDR Text Key: 5525820
• Report Number: 3002037047-2015-00042
• Device Sequence Number: 1
• Product Code: KYG
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2015
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: UNSPECIFIED 2.8 MM KNIFE