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

Catalog Number 8065752101

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2020

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 customer reported that the root of the tube was found to be bent when opened the pak.Customer proceeded with the procedure and it became unusable during the procedure.The product was replaced and procedure completed with no patient harm.There is a suspicion of irrigation or aspiration failure.

Manufacturer Narrative

Additional information provided in d.10., h.3., h.6., and h.10.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.A turbid fluid management system (fms) was returned and evaluated.The returned sample was visually inspected and build-up of surgical residue was observed in the drain bag and throughout the fms indicating re-use of a single-use device.Yellowish surgical fluid was inside the tubing.There was a slight bend in the tubing, however, based on the reused condition of the sample, this could have occurred post receipt of the sample.The affiliate stated that the product was not reprocessed or reused; however, the customer should be reminded the direction for use (dfu) states that alcon products are validated for single-use only and should not be reprocessed or reused.It has been found in lab testing that excessive use of any single-use product may contribute to functional breakdown.A calibrated console was used to test the sample and the fms cassette primed and tuned with the ultrasonic handpiece successfully and could achieve maximum vacuum.No system message was generated, no fluid or air leaks, and no cracks were observed on the connectors that would have contributed to the reported event.The irrigation and aspiration flow rates were measured and found to be within specifications.Fluid flowed from the balanced salt solution bottle to the irrigation and aspiration manifolds and continuously to the cassette housing.No occlusion or obstruction was observed during inspection and functional testing.While the pass all functional and performance requirements and functioned as intended during laboratory testing, surgical residue build-up was identified throughout the cassette device and tubing manifolds suggesting the cassette was reused.Based on the condition of the cassette, the root cause of the customer's cassette is related to customer reuse of a single-use device.As described, excessive use of any single-use product may contribute to functional breakdown.No action will be taken for this occurrence, as the root cause is related to customer reuse of the product.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 has been made aware of this complaint.The manufacturer internal reference number is:(b)(4).

• Brand Name: INFINITI 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: 9948480
• MDR Text Key: 187912787
• Report Number: 1644019-2020-00204
• 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: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 8065752101
• Device Lot Number: 2290432H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2020
• Date Manufacturer Received: 06/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASSY,SHIP,OZIL INFI JAPAN.