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

Catalog Number 8065750517

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2018

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.A product sample has been received by the manufacturer and it is awaiting evaluation.(b)(4).

Event Description

A surgeon reported the infusion sleeve got caught in the incision when inserted and removed during a procedure.The product was replaced and there were no issues with the replacement sleeve.The procedure was completed and there was no harm to the patient.No additional information is expected.

Manufacturer Narrative

There have been no additional complaints reported against the finish goods lot and the device history record shows the product was released per specifications.The customer returned one infusion sleeve with the bubble suppression insert (bsi), the infusion sleeve was visually inspected and no obvious defects were found.The irrigation holes were aligned 180° opposite to each other, the texture on the inner wall of the infusion sleeves was intact and no deformity was observed on the shaft of the infusion sleeve and the bsi.The infusion sleeve was able to be stalled on a mini flare tip from the lab stock on the handpiece, no twist was observed on the sample when performing the twist test on the tip and the center port of the infusion sleeve was fitted correctly on the tip.Using the infiniti console to test the returned infusion sleeve on the tip and handpiece was performed.The flow rate and irrigation free flow rates were within specification.The root cause of the customer's complaint could not be established; the returned sample met specifications, no issues were found with the infusion sleeve during testing.No contributing factors could be identified that could cause the customer¿s experience.After a thorough investigation of this complaint, it has been determined that this sample met specifications.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: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7436182
• MDR Text Key: 105884021
• Report Number: 1644019-2018-00108
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• 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: 8065750517
• Device Lot Number: 2107836H
• Other Device ID Number: 380657505173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2018
• 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