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

Catalog Number 8065752450

Device Problem Material Separation (1562)

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

Event Date 05/03/2021

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 nurse reported the body of the vitrectomy probe was separated and wrapped during a vitrectomy procedure.There was no patient harm.

Manufacturer Narrative

A sample was not received at the manufacturing site for evaluation; therefore, the condition of the product could not be verified.The product was processed and released according to the product¿s acceptance criteria.A sample was not received at the manufacturing site and the product was processed and released according to the product¿s acceptable criteria, therefore; the root cause for the customer complaint issue cannot be determined.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

One opened probe was received with a tip protector, in a tray along with other items.The returned sample was visually inspected and found to be non-conforming with the probe body separated from the rest of the probe assembly and the needle bent.The probe was disassembled and the components inspected.No/minimal wear was observed on the inner cutter of when compared to the degree of wear based on continuous actuation of the probe visual standard photos.The inner cuter was observed to be slightly bent and presence of adhesive was observed on the probe body and engine housing assembly.The complaint evaluation confirms that the probe body was detached.The root cause of the detached probe body is insufficient adhesive amount and cure fiber distance from part during the curing process step.An internal investigation has been completed and action is presently being implemented to reduce the frequency of shell detachments.Probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Any non-conformances found are removed from the lot and scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION 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: 11819774
• MDR Text Key: 250636032
• Report Number: 1644019-2021-00333
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657524501
• UDI-Public: 00380657524501
• Combination Product (y/n): N
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 8065752450
• Device Lot Number: 2423671H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Date Manufacturer Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1