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

Catalog Number 8065752015

Device Problem Mechanical Jam (2983)

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

Event Date 05/24/2018

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.(b)(4).

Event Description

A surgeon reported the tools got caught in the trocar cannula when inserting and removing during a procedure.The procedure was completed without product replacement and with no harm to the patient.No additional information is expected.

Manufacturer Narrative

One trocar hub/cannula assembly and an infusion cannula were received in a bag for the report of tools got caught in trocar cannula.The trocar sample was visually inspected and was found to be conforming.The sample was then dimensionally inspected for cannula inner diameter after removing any procedural residue and was found conforming.A functional fit test could not be performed as the associated product (infusion cannula) was forwarded to the appropriate manufacturing site for evaluation and was not retained by the manufacturing site of the trocar.The returned infusion cannula sample was visually inspected and no obvious defects were found.The gauge size was confirmed with a go-no-go gauge.The infusion cannula line was inserted into a 25 gauge trocar and the green fitting was connected to an infusion manifold from lab stock.Replacing the missing components with those from lab stock, the sample was tested on a console.With the infusion control on, the returned sample was tested for one minute and no leakage occurred.A review of the trocar 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 complaint history examination indicates there are no additional complaints associated with the lot for the reported issue.The infusion cannula lot complaint history was reviewed.This is the eighth complaint for the finish goods lot; however, first for this issue for this lot.The device history record shows the product was released per specifications.The returned trocar was found to be conforming and the returned infusion cannula functioned per specification, therefore a product fit issue as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.No action was taken as the trocar and infusion cannula were manufactured to specifications.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No further actions are required.Consumables manufacturing management has been made aware of this complaint through the consumer affairs review meeting.(b)(4).

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 7670775
• MDR Text Key: 113644104
• Report Number: 1644019-2018-00162
• 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: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 8065752015
• Device Lot Number: 2139880H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2018
• Initial Date Manufacturer Received: 06/12/2018
• Initial Date FDA Received: 07/09/2018
• Supplement Dates Manufacturer Received: 09/11/2018
• Supplement Dates FDA Received: 10/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM
• Patient Outcome(s): Other