MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CUSTOM-PAK SURGICAL PROCEDURE PACK; GENERAL SURGERY TRAY (KIT)

Catalog Number AS3127-58

Device Problem Dull, Blunt (2407)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/18/2019

Event Type  malfunction  

Manufacturer Narrative

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.The manufacturer internal reference number is: (b)(4).

Event Description

A healthcare professional reported that a knife blade was not sharp upon making the initial incision during a procedure.The knife was replaced and procedure completed.Patient impact information is unknown.

Manufacturer Narrative

The returned blade was visually inspected under light-microscopy and no burrs or dullness on the blade was observed.The reported lot device history record was reviewed and it was confirmed that a temporary blanket deviation was initiated on the finished good lot.The knife that the customer prefers resumed usage in the pak builds beginning 4/22/19.Any paks built before this date will contain the temporary deviation knife.The substitute knife form, fit and function is the same previous knife.The root cause of the customer¿s dissatisfaction with the knife substitution is due to a temporary deviation which occurred due to a backorder with the supplier.During the back-order, a substitute knife was approved for use.Evaluation of the knife did not find any burrs or visual dullness on the blade.Quality engineering materials will notify the supplier of the complaint per procedure.Quality assurance will continue to monitor and take action for any future occurrences as is deemed necessary.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.Quality engineering materials will be notified of this complaint through the monthly complaint review meeting.The manufacturer internal reference number is: (b)(4).

• Brand Name: CUSTOM-PAK SURGICAL PROCEDURE PACK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 8577505
• MDR Text Key: 144255846
• Report Number: 1644019-2019-00074
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: AS3127-58
• Device Lot Number: 2241787H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Date Manufacturer Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1