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

Catalog Number 8065751462

Device Problems Break (1069); Device Fell (4014)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/07/2019

Event Type  Injury  

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 customer reported, during a vitrectomy procedure of the left eye, the cannula fell apart in the eye and caused a hemorrhage.The surgeon was able to remove the two pieces from the eye that fell apart and he was able to stop the bleeding from the hemorrhage and completed the procedure.The customer stated she can't return the product or pieces at this time as the facility plans to perform their own investigation.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was provided.The customer indicated the bleeding event was temporary and resolved itself.The patient was doing well and they plan to return the cannula.

Manufacturer Narrative

One opened trocar cannula and trocar hub were received.The returned sample was visually inspected and was found nonconforming, the trocar cannula and trocar hub are separated.There was damage to the middle of the trocar cannula, it has a compressed appearance and there was adhesive present inside of the hub and on the od (outer diameter) of the cannula.During assembly of the trocar product adhesive is dispensed at the cannula hub interface.The evaluation of the returned sample identified adhesive inside of the hub, therefore, how and when the trocar cannula and hub became separated and the trocar cannula became damaged cannot be determined from this evaluation and the root cause for this complaint is unknown.A potential contributing factor of the separation is manipulation during surgery.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.Assemblies are 100% inspected for adhesive application during assembly.If adhesive application is incorrect the assembly is scrapped.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information provided in g.1., g.2., h.6., and h.10.A sample was not received at the manufacturing site for evaluation for the report of trocar cannula fell apart; however the attached customer photo does confirm that the trocar hub is separated from the trocar cannula.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.The evaluation of the returned customer photo confirmed the reported issue of the trocar fell apart; however, how and when the trocar cannula and hub became separated cannot be determined from this evaluation and the root cause for this complaint is unknown.A potential contributing factor of the separation is manipulation during surgery.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.Assemblies are 100% inspected for adhesive application during assembly.If adhesive application is incorrect the assembly is scrapped.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION 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: 9401022
• MDR Text Key: 168786283
• Report Number: 1644019-2019-00185
• 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: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 8065751462
• Device Lot Number: 2263626H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Date Manufacturer Received: 04/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM.; CONSTELLATION VISION SYSTEM
• Patient Outcome(s): Other
• Patient Age: 61 YR