MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HOUSTON LEGACY SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)

Catalog Number 8065750517

Device Problem Material Twisted/Bent (2981)

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

Event Date 02/27/2018

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 facility reported that the sleeve was twisting during the irrigation-aspiration step of a cataract procedure.The procedure was completed.There was no patient harm reported.According to the surgical equipment manager, it was determined that the surgeon was inadvertently winding the irrigation sleeve too far distally and causing the sleeve to bunch up behind the flared part of the polymer tip.A short in-service resolved the issue with no further incidents so far.This is one of three reports received from this facility.

Manufacturer Narrative

As the customer did not retain the finished goods lot number, device history record and lot history could not be reviewed.The customer did not retain a sample for this complaint report; visual inspection or functional testing could not be conducted.If a sample is returned at a later date, the investigation will be reopened and the sample evaluated.The surgical account manager stated that the surgeon was inadvertently winding the irrigation sleeve too far distally and caused the sleeve to bunch up behind the flare part of the polymer tip.After a short in service the issue was resolved.The root cause of the customer's complaint was caused by the surgeon inadvertently winding the irrigation sleeve to far on the polymer tip cause the sleeve to twist or bunch up on the tip.The issue was resolved after a short in service was done with the surgeon.After a thorough investigation of this complaint, it has been determined that no action will be taken at this time.Quality assurance will continue to monitor customer complaints via the complaint review meetings, and will take action for any future occurrences as is deemed necessary.Consumables manufacturing management has been made aware of this complaint through the consumer affairs review meeting.(b)(4).

• Brand Name: LEGACY SURGICAL PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7365869
• MDR Text Key: 103533359
• Report Number: 1644019-2018-00064
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065750517
• Device Lot Number: ASKU
• Other Device ID Number: 380657505173
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other