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

Catalog Number 8065752900

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2021

Event Type  malfunction  

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 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.

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
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 11643278
• MDR Text Key: 244727059
• Report Number: 1644019-2021-00241
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657529001
• UDI-Public: 00380657529001
• Combination Product (y/n): N
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 03/29/2021
• Initial Date FDA Received: 04/09/2021
• Supplement Dates Manufacturer Received: 06/25/2021
• Supplement Dates FDA Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1