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

Catalog Number 8065000096

Device Problem Detachment of Device or Device Component (2907)

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

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 physician reported the head part of a trocar and its rod got separate after an equipment was put in and out of it a few times during a vitrectomy procedure.The procedure was completed after replacing the product.There was no patient harm.

Manufacturer Narrative

One opened 27 gauge (ga) trocar hub with part of the cannula attached and the broken part of the cannula taped to a piece of gauze in a tray were received.The returned trocar cannula/hub assembly was visually inspected and was found to be non-conforming, the trocar cannula was broken below the trocar hub.A review of the device history record traceable to the reported lot number, indicates that the product was processed and released according to the product¿s acceptance criteria.The exact root cause could not be determined from the investigation performed.The returned sample is visually non-conforming with the trocar cannula broken below the hub; therefore, the trocar product complaint is confirmed; however, how and when cannula became broken could not be determined.The cause of the reported event cannot be determined with the information obtained, therefore, specific action with regards to this complaint cannot be taken.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 additional action is required at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PACK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 12134758
• MDR Text Key: 260459493
• Report Number: 1644019-2021-00460
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380650000965
• UDI-Public: 00380650000965
• 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
• Report Date: 10/04/2021

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 Expiration Date: 01/31/2023
• Device Catalogue Number: 8065000096
• Device Lot Number: 2454678H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Initial Date Manufacturer Received: 07/08/2021
• Initial Date FDA Received: 07/08/2021
• Supplement Dates Manufacturer Received: 09/29/2021
• Supplement Dates FDA Received: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1