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

Catalog Number	8065751577
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
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 physician reported a trocar cannula port from the chandelier pack broke during usage in a procedure.The product was replaced and the procedure was completed.There was no patient harm.
Additional Manufacturer Narrative
One opened 25 gauge (ga) trocar handle/blade assembly w/tip protector and a cannula in a pouch were received.The returned trocar cannula/hub assembly was visually inspected and was found to be non-conforming, the hub was missing from the cannula.There was presence of adhesive on the cannula.A review of the device history record traceable to the reported lot number, indicates that the product was processed and released according to the product¿s acceptance criteria.During assembly of the trocar product adhesive is dispensed at the cannula hub interface.The evaluation of the returned sample, identified adhesive on the cannula.Therefore, how and when the trocar cannula and hub became separated cannot be determined, from this evaluation.And the root cause for this complaint is unknown.A potential contributing factor of the separation is manipulation during surgery.The exact root cause for this complaint is unknown.Therefore, specific action with regards to this complaint cannot be taken.Assemblies are 100% inspected for adhesive application during assembly.If adhesive application is incorrect the assembly is scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed, associated with the reported product and event.No further actions are required.The manufacturer internal reference number is: (b)(4).

• Brand Name: FIBER OPTIC ILLUMINATOR
• Common Device Name: LIGHT, SURGICAL, FIBEROPTIC
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 12626032
• Report Number: 1644019-2021-00633
• Device Sequence Number: 14539073
• Product Code: FST
• UDI-Device Identifier: 00380657515776
• UDI-Public: 00380657515776
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K875005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2021

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: 11/30/2022
• Device Catalogue Number: 8065751577
• Device Lot Number: 2439003H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONSTELLATION VISION SYSTEM; CONSTELLATION VISION SYSTEM
• Patient Sex: Unknown