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

Catalog Number 8065751767

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/21/2022

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 the hose disconnected from its axis, it was glued which was a factory defect during a vitrectomy procedure.The product was replaced and the procedure was completed.There was no report of patient harm.Additional information has been requested, however none has been received till date.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received from company representative who indicated that the scheduled procedure was posterior vitrectomy with retinopexy ¿ chorioretinal lesion ablation procedure and was performed on the right eye.

Manufacturer Narrative

Additional information provided in d.9., h.3., h.6.And h.10.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 customer reported that the infusion air infusion valve (aiv) filter was broken in their pak.One used combined pak was visually inspected.The housing of the auto stopcock fell apart.The top and base auto stopcock housing appeared to have been insufficiently welded.The root cause of the customer's complaint was determined to be related to equipment not maintaining consistent control of the weld process.Contributing factors identified were training issues during production when performing the integrity squeeze check on the component to verify a good weld and when performing maintenance on the equipment.Action was taken to determine root cause and to take appropriate corrective actions for complaints of a similar nature.Quality assurance identified the likely contributors to be related to equipment end of life and will be replaced with a new system.Procedural enhancements were also implemented for better control of process during quality checks and for better training of personnel during production and equipment maintenance.Complaints are reviewed and monitored at regular intervals for adverse trends.No further action has been identified for this reported 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 ; 8007579780
• MDR Report Key: 14135871
• MDR Text Key: 289449727
• Report Number: 1644019-2022-00278
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657517671
• UDI-Public: 00380657517671
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/22/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 8065751767
• Device Lot Number: 2458970H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2022
• Initial Date FDA Received: 04/18/2022
• Supplement Dates Manufacturer Received: 04/26/2022; 07/08/2022
• Supplement Dates FDA Received: 05/16/2022; 07/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Male