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

Catalog Number 8065751765

Device Problem Fluid/Blood Leak (1250)

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

Event Date 06/16/2021

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 cassette was noticed with water leakage before a vitrectomy procedure.The cassette was replaced and the procedure was completed.There was no patient harm.

Manufacturer Narrative

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.No sample has been returned for evaluation.Therefore, the condition of the product could not be verified.The root cause of the customer's complaint could not be established, as a sample has not been received.And the condition of the product could not be verified.Without analysis of the sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship if any, of the device to the reported incident cannot be determined.The root cause for this complaint is not known.Therefore, specific action with regards to this complaint cannot be taken.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

Event Description

There was no patient involvement.

Manufacturer Narrative

(b)(4).The wet product was visually inspected and it was observed that one of the identification (id) tabs was broken off.A calibrated console representing the current software version was used to test the sample.A system message code displayed on the console screen to state: "invalid cassette id detected.Please eject and insert a valid cassette." the submerge leak test was performed on the cassette and no leakage was observed.The root cause of the customer's complaint could not be determined conclusively as no leakage was detected.The broken id tab issue would not have resulted in product leakage.Action will not be taken for this occurrence.After investigation of this complaint and analysis of complaints of this nature confirm no unfavorable trend for this event.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.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
• Manufacturer (Section G): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514979
• MDR Report Key: 12017079
• MDR Text Key: 256735949
• Report Number: 1644019-2021-00405
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657517657
• UDI-Public: 00380657517657
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• 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: 8065751765
• Device Lot Number: 2423678H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1