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

Catalog Number 8065751657

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/21/2020

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 to a company representative that the trocar cannula's valve became dislodged inside a patient's eye during a procedure.There was no harm to the patient.Additional information was received from the surgeon who indicated one of the valve flaps stuck to an instrument and when she removed the instrument, the flap got stuck inside the trocar.She used forceps to remove the loose flap.This is one of two reports for this surgeon.

Manufacturer Narrative

Additional information provided in h.10.Correction provided in b.2.The initial decision to report was incorrect resulting in the initial report being submitted in error.This report does not meet criteria for reporting as a device malfunction.A valve flap sticking to an instrument, getting stuck inside the trocar followed by removal with forceps does not pose a potential risk or likelihood or injury if it were to recur.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, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 10021802
• MDR Text Key: 190117078
• Report Number: 2028159-2020-00371
• Device Sequence Number: 1
• Product Code: NGY
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065751657
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DIATHERMY PROBE DSP; FLEX LASER PROBE
• Patient Age: 64 YR