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

Catalog Number 8065752020

Device Problems Device Slipped (1584); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2015

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

An ophthalmic surgeon reported that the trocar port was pulled out when removing the vitrectomy probe during a vitreoretinal procedure.The issue was resolved by replacing the product.There was no report of patient harm.

Manufacturer Narrative

The trocar cannula was not returned for evaluation.The returned probe sample was visually inspected and was deemed nonconforming.The needle is bent and has a clear foreign material approximately ¼ the distance down the needle surface from the distal location.The visual appearance of this foreign material does not match the visual appearance of the related complaint having the same lot and reported issue.The needle outer diameter was measured and found to be conforming at the needle diameter region where the foreign material is not present, but nonconforming at the area where foreign material is present.The probe needle, with the foreign material, was initially fit tested for function into a conforming trocar and was deemed nonconforming.The foreign material was wiped off the needle with alcohol and reinserted in the trocar.The probe fit test into a trocar was then deemed conforming, with the needle easily inserting completely through the trocar.A device history record review for the lots was conducted.No anomalies were found during the device history record reviews.The product was released according to the product¿s acceptance criteria.A complaint lot history examination indicates there was one other complaint for the reported issue.The complaint evaluation does confirm the returned probe was not able to fit through a trocar.The root cause for the stuck probe in the trocar was due to the foreign material.When and how this material became attached to the needle and what this foreign material composition cannot be determined from this evaluation; however, based on the ability to wipe the foreign material off the needle, it is unlikely the material originated during the manufacturing of the probe.(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
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5180684
• MDR Text Key: 30045600
• Report Number: 1644019-2015-01161
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: 8065752020
• Device Lot Number: 1734551H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2015
• 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