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

Catalog Number 8065751902

Device Problem Difficult To Position (1467)

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

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 customer reported experiencing difficulty with insertion and removal of instrumentation from the trocars.A trocar was observed coming out of the sclera.The procedure was completed without exchanging the trocars.There was no patient harm.Additional information and product samples have been requested.

Manufacturer Narrative

A review of the related device history records for 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.Two opened trocar cannula/hub assemblies were received.The returned samples were visually inspected and were both conforming.Both samples were then dimensionally inspected for cannula id and were found conforming.A functional fit check was then performed with the probe and the illuminator that were returned with the trocars and was found conforming.One illuminator was returned for evaluation.The illuminator was visually examined and deemed nonconforming, due to what appears to be from handling.The illuminator cannula is bent just above the stiffener sleeve at approximately 15 degrees and then has a second bent cannula location at the top ¼ region of the cannula of over 90 degrees.The cap over the needle is placed on backwards, which may explain the extremely bent condition of the cannula at its bent location toward the distal location.The cannula shows no surface imperfections or excess foreign material present.The sample was functionally tested for fit through a conforming 25ga trocar.The cannula did pass easily through the trocar until in encountered the bent cannula.The cannula diameter was measured before and after the bent region of the needle and was conforming.One probe sample was returned for evaluation.The probe sample was visually inspected and was deemed nonconforming.Foreign material is present on the cannula surface.The needle middle and body side outside diameter were measured and deemed conforming.The diameter where the foreign material is present is nonconforming.The diameter measurement, after the foreign material was wiped off, was conforming.The probe needle was fit tested for function into a conforming trocar and was deemed conforming after the foreign material was removed.A root cause cannot be determined for the complaint as described by the customer.The most likely reason for the trocar not being removed from the trocar was due to the cannula being bent during its use and this does not point to a manufacturing issue.No action was taken as the product was manufactured to specifications.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No additional action is required at this time.(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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 5946447
• MDR Text Key: 54956364
• Report Number: 1644019-2016-01237
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 8065751902
• Device Lot Number: 1890709H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• 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