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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 8065751617
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/12/2023
Event Type  malfunction  
Event Description
A physician reported that cutter was detached from the tube during the surgery.The surgery was completed after replacing the pak with another one.There was no patient harm.The procedure type is unknown.
 
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
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 returned sample was visually inspected and confirmed the probe associated with the pak was not returned by the customer.The root cause is unknown.As the customer did not return all components associated with this complaint sample, a full evaluation could not be performed.As described, it is important to remind the customer to return all products associated with the event for a full evaluation.No action will be taken for this occurrence, as the root cause is unknown.No adverse trends have been observed associated with the reported product and event.Quality assurance will continue to monitor customer complaints via the complaint review meetings and will take action for any future occurrences as is deemed necessary.Consumables manufacturing has been made aware of this complaint.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 Key17342198
MDR Text Key319483259
Report Number1644019-2023-00908
Device Sequence Number1
Product Code LRO
UDI-Device Identifier00380657516179
UDI-Public00380657516179
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K880961
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/30/2023
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 Number8065751617
Device Lot Number14YVEN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/22/2023
Initial Date FDA Received07/18/2023
Supplement Dates Manufacturer Received10/10/2023
Supplement Dates FDA Received10/30/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/23/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
CONSTELLATION VISION SYSTEM
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