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

Catalog Number 8065750517

Device Problems Difficult to Insert (1316); Material Too Rigid or Stiff (1544)

Patient Problem Insufficient Information (4580)

Event Date 10/06/2020

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 pharmacist reported that the sleeve was not sufficiently rigid and it is difficult to fit the handpieces in the incision.Patient and procedure impact are unknown.Additional information has been requested.

Manufacturer Narrative

A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.Two 0.9 mm ultra infusion sleeves in the small part tray in the pouch was returned and visually inspected.No deformity was observed on the shaft of the infusion sleeves.The irrigation holes were aligned 180° opposite to each other.The texture on the inner wall of the infusion sleeves was intact.A twist test was performed to check the interference fit between the sleeves and the lab stock 0.9 mm abs tip on the ultrasonic handpiece to ensure the tolerance between the sleeve and abs tip shaft was conforming.No twist was observed on the samples when performing the twist test.The root cause of the customer's complaint could not be established as the infusion sleeve was mounted onto the tip shaft and no anomalies were observed.No action will be pursued at this time for this occurrence.All lots are verified that all required inspections have been performed and all acceptance criteria are met prior to release.Additionally, alcon has asked sales to educate the customer on proper custom pak handling and storage.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending.The manufacturer internal reference number is: (b)(4).

• Brand Name: LEGACY SURGICAL PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 10747935
• MDR Text Key: 214804307
• Report Number: 1644019-2020-00573
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 8065750517
• Device Lot Number: 2366973H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1