MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CENTURION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)

Catalog Number	8065752900
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
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 customer reported that the infusion sleeve was easily cut and was unusable during a procedure.The product was replaced and procedure completed with no patient harm.
Additional Manufacturer Narrative
Additional information provided in d.9, h.3, h.6 and h.10.The customer did not retain the product lot information for this infiniti procedure pack, therefore the device history records traceable to the reported procedure pack could not be reviewed.The customer reported that the infusion sleeve was to fragile.The returned sample was visually inspected and the issue was confirmed, a cut was found in the shaft of the infusion sleeve.The damage appears to have what resembles phaco tip piercing damage at the center section of the shaft.The root cause of the customer¿s complaint is most likely related to user handling during set-up.The marks on the sleeve have what resembles phaco tip damage; when the sleeve was installed over the phaco tip and the tip pierces the sleeve.After the investigation of this complaint, it has been determined that no action will be taken at this time as the root cause is unknown; however, user handling is suspected.Quality assurance will continue to monitor customer complaints via the complaint review meetings, and will take action for any future occurrences as is deemed necessary.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION SURGICAL PROCEDURE PAK
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 11643278
• Report Number: 1644019-2021-00241
• Device Sequence Number: 3124537
• Product Code: LRO
• UDI-Device Identifier: 00380657529001
• UDI-Public: 00380657529001
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• 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 Catalogue Number: 8065752900
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1