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

Catalog Number	8065751185
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that the endoilluminator was stuck in trocar during surgery with no patient contact.The surgery was completed after replacing the product with new one.There was no patient harm reported.
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).
Additional Manufacturer Narrative
The opened illuminator returned for evaluation for the report was not within the final lot number reported based on radio frequency identification tag identification; therefore, no sample evaluation was performed.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.Since the sample associated with the reported product and lot number was not received at the manufacturing site, and the device history record review of the lot number provided indicated the product was processed and released according to the product¿s acceptable criteria; the root cause for the customer complaint issue cannot be determined.The returned sample was not within the final lot number based on radio frequency identification tag identification; therefore, specific actions with regard to this complaint cannot be taken.All fiber optic light guide products are 100% visually inspected and light tested for transmittance and image during manufacturing.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: 17191420
• Report Number: 1644019-2023-00760
• Device Sequence Number: 12615879
• Product Code: FST
• UDI-Device Identifier: 00380657511853
• UDI-Public: 00380657511853
• 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: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2023

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: 06/30/2024
• Device Catalogue Number: 8065751185
• Device Lot Number: 2503501H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2021
• 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
• Patient Sex: Unknown