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

Catalog Number	8065751614
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2022
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 healthcare professional reported that cutters were cutting intermittently and then there was no cutting.Problem was with the pneumatic assembly panel that had been replaced.The procedure details and patient impact were not provided.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Corrected information is provided in sections h.10 and h.11.Upon further review of the available information, this report of a cutter intermittently cutting and then not cutting, does not meet criteria for reporting based on applicable medical device regulations.The initial decision to report was incorrect resulting in the initial report being submitted in error.This event is not considered to be a reportable malfunction, and it is not likely that a recurrence would result in serious injury.No further reports will be reported under mfg.Report num.1644019-2022-00548.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PAK
• Common Device Name: 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 ; 8007579780
• MDR Report Key: 14973667
• Report Number: 1644019-2022-00548
• Device Sequence Number: 5631664
• Product Code: LRO
• UDI-Device Identifier: 00380657516148
• UDI-Public: 00380657516148
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2022

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 Expiration Date: 11/30/2023
• Device Catalogue Number: 8065751614
• Device Lot Number: 2541240H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2022
• Supplement Date Received by Manufacturer: 07/09/2022; 09/07/2022
• Initial Report FDA Received Date: 07/09/2022
• Supplement Report FDA Received Date: 08/04/2022; 10/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONSTELLATION VISION SYSTEM
• Patient Sex: Unknown