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

Catalog Number 8065752015

Device Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2016

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 that the light guide was not able to go through the trocar, and it got stuck.The light guide was replaced and the procedure was completed without harm to the patient.A product sample was requested for evaluation.There are no other event details available.

Manufacturer Narrative

An illuminator probe sample was returned for evaluation.The final product lot was identified.A device history record review for the lot was conducted.According to the device history record review the lots were reprocessed for anomalies that did not contribute to the customer complaint.The product was released according to the product¿s acceptance criteria.The illuminator was visually examined using 10x magnification and deemed nonconforming.The illuminator has a milky white foreign present on the cannula needle.The needle was measured and had a conforming diameter dimension where the foreign material was not present and was deemed nonconforming where the foreign material was present.The sample was functionally tested for fit through a conforming trocar.The section of the needle where the foreign material was present on the needle did not pass through the trocar.The foreign material was cleaned with a tissue and the foreign material was easily removed.The sample was functionally tested again and did fit through the trocar.The material was also then dimensionally conforming.The investigation does confirm that the illuminator could not fit through the trocar in the condition returned.The evaluation cannot determine what the foreign material was and does not appear to be manufacturing adhesive since it was able to remove so easily.When and how this unknown material became present on the illuminator cannot be determined from this evaluation.One opened trocar assembly in a pouch was received for evaluation.The returned sample was inspected and was determined to be visually conforming (the sample contained a small amount of procedural residue).A product fit test was determined to be conforming and a dimensional inspection confirmed the product met specification.The final customer lot was identified.A device history record review was conducted.There were no anomalies found based on the device history record review.All visual and functional tests performed during the evaluation were conforming.Difficulty with inserting or removing devices from the trocar are often attributable to surgical debris or the mating device that is inserted into the trocar cannula.Once cleaned, the illuminator was able to be passed through the trocar cannula and this may have been a factor that was encountered during the procedure.The exact root cause for the report is unknown.(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: 5416156
• MDR Text Key: 37726900
• Report Number: 1644019-2016-00186
• 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: 05/05/2016

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: 08/31/2017
• Device Catalogue Number: 8065752015
• Device Lot Number: 1794211H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2016
• Initial Date FDA Received: 02/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2015
• 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