MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER EDGEPLUS VALVED ENTRY SYSTEM; CANNULA, TROCAR, OPHTHALMIC

Catalog Number 8065751658

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2017

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 to a company representative the valved trocar detached from the sclera during removal of the laser probe during an unknown number of vitreo-retinal procedures.Forceps were required to removed the valved trocar from the laser probes.There was no harm to the patients and the samples were not retained.Additional information was requested; however, none has been received to date.This is one of two reports.

Manufacturer Narrative

Product evaluation ¿ probe the customer reported that removing their laser probe detached the valved trocar from the sclera.The illuminated flex curved laser probe was received and a visual assessment of the returned sample was performed.It showed that the nitinol was loose, indicating that it is not properly bonded to the cannula.However, this is determined to be unrelated to the reported event.The sample was inserted into a 25 gauge trocar cannula and passed through with no noticeable resistance.The sample¿s outer cannula diameter was measured and found to meet specifications.It should be noted that the laser probes are visually inspected during manufacturing to verify the tips are conforming.A review of the manufacturing records did not reveal any related non-conformity during manufacturing for this product.The product met specifications at the time of release.Product evaluation - 25g entry pak no sample has been returned for evaluation for the report of trocar detached from sclera during removal; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, lot history and complaint history reviews could not be conducted.All trocar are 100% inspected by the automated assembly machine for gauge size.Any non-conformances found are removed from the lot and scrapped.The root cause cannot be determined conclusively.The manufacture will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: EDGEPLUS VALVED ENTRY SYSTEM
• Type of Device: CANNULA, TROCAR, OPHTHALMIC
• Manufacturer (Section D): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7056717
• MDR Text Key: 93213457
• Report Number: 2028159-2017-04366
• Device Sequence Number: 1
• Product Code: NGY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065751658
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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