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U.S. Department of Health and Human Services

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

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ALCON RESEARCH, LLC - HOUSTON CONSTELLATION SURGICAL PROCEDURE PACK; GENERAL SURGERY TRAY (KIT) Back to Search Results
Catalog Number 8065752436
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
A nurse reported that the tubing was detached during vitrectomy surgery and attempted to re-attach the tubing but was unsuccessful.The surgery was completed after replacing the product with new one.There was no patient harm.
 
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).
 
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.Upon visual inspection of the returned probe, both pneumatic drivelines were detached from the probe.Under magnification we confirmed the presence of adhesive residue around the tubing and a residue line on the tubing indicate both drivelines were fully inserted into the probe ports at one time.With the amount of residue remaining on the tubing for both lines, we could not conclude if this issue was the result of a adhesive application issue.The signs observed on the distal end of each tubing indicate the presence of adhesive.In order to mitigate the occurrence of this type of event, during the manufacturing process, in-process checks during assembly and after final assembly are utilized to help screen out this type of defect from occurring.The root cause of the customer's complaint could not be conclusively determined based on the result of the investigation.A potential root cause could be related to the bonding process, however, this cannot be confirmed with the available information.No root cause could be conclusively determined, therefore no corrective action is required at this time.Based on our current tracking, there are no adverse trends for this reported complaint and lot.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).
 
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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
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 Key17077788
MDR Text Key316877154
Report Number1644019-2023-00674
Device Sequence Number1
Product Code LRO
UDI-Device Identifier00380657524365
UDI-Public00380657524365
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K880961
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 09/05/2023
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 Catalogue Number8065752436
Device Lot Number158NYT
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/11/2023
Initial Date FDA Received06/07/2023
Supplement Dates Manufacturer Received08/11/2023
Supplement Dates FDA Received09/05/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/12/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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