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	02/25/2021
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
The customer reported that the trocar broke when inserting instrument.Additional information has been requested.
Event or Problem Description
The customer reported that the trocar broke when inserting instrument.The chandelier was replaced and the procedure was completed.There was no patient impact.
Additional Manufacturer Narrative
One opened 25 ga trocar handle/blade assembly with a protector and a cannula/hub assembly on a chandelier in a pouch was received for the report of the trocar was broken.The returned trocar cannula/hub assembly was visually inspected and was found to be conforming.The cannula/hub assembly was then functionally tested with the push out test and was found to be conforming.The product was processed and released according to the product¿s acceptance criteria.The returned sample was found to be conforming, therefore the trocar broken issue as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.No action was taken as the trocar was manufactured to specifications.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
• MDR Report Key: 11529681
• Report Number: 1644019-2021-00183
• Device Sequence Number: 14755354
• Product Code: FST
• UDI-Device Identifier: 00380657515776
• UDI-Public: 380657515776
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K875005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2021

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: 09/30/2021
• Device Catalogue Number: 8065751577
• Device Lot Number: 2330403H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 06/28/2021
• Patient Sequence Number: 1