MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON FIBER OPTIC ILLUMINATOR; LIGHT, SURGICAL, FIBEROPTIC

Catalog Number	8065751486
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
Additional 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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that the light pipe cannula was removed from the handle and stayed inside the trocar inside the eye.The product was replaced and the procedure was competed.There was no patient harm.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6., and h.10.Correction provided in b.5., d.4.And h.4.An opened illuminator was returned for evaluation for the report of light pipe cannula removed from handle and stayed inside the trocar inside the eye.A review of the device history record traceable to the reported lot number, indicated that the product was processed and released according to the product¿s acceptance criteria.The illuminator was visually inspected and deemed nonconforming, the cannula needle and stiffener were missing.The illuminator was disassembled.The cannula needle was found retracted inside the distal handpiece, the fiber-coupling-needle assembly was detached from the illuminator tip.Adhesive present.Fiber looped inside.A dimension test was performed, the cannula needle outside diameter was measured and deemed conforming.A functional fit check using a conforming trocar was performed and deemed conforming.The cannula needle passed through the conforming trocar.The complaint evaluation does not confirm the cannula stayed in the trocar inside the eye, the cannula needle was found retracted inside the distal handpiece.Furthermore, the complaint evaluation confirms the report of light pipe cannula removed from handle due to a detachment between the fiber-coupling-needle assembly and the illuminator tip.How and when this detachment occurred cannot be determined from this evaluation.The root cause for the detachment is due to an adhesive failure between components, but the reason for this failure cannot be determined from this evaluation.Force would be needed to break the bond between the components, but the source of this force cannot be determined from this evaluation.An internal investigation was completed and additional controls within the manufacturing process have been implemented to minimize the potential for fiber optic detachment.All light guide products are 100% visually inspected and light tested to insure good visual attributes and a good light output are present prior to release of the product.All illuminators are also 100% pull tested to insure the distal components are secure.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed for this reported event.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
This occurred during a vitrectomy surgery.

• Brand Name: FIBER OPTIC ILLUMINATOR
• Common Device Name: LIGHT, SURGICAL, FIBEROPTIC
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 11896934
• Report Number: 1644019-2021-00371
• Device Sequence Number: 11083851
• Product Code: FST
• UDI-Device Identifier: 00380657514861
• UDI-Public: 00380657514861
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K875005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 8065751486
• Device Lot Number: 2466023H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1