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U.S. Department of Health and Human Services

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

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ALCON RESEARCH, LLC - HOUSTON CONSTELLATION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT) Back to Search Results
Catalog Number 8065751765
Device Problem Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/02/2022
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 nurse reported trocar adhering to the instruments and not allowing the usual vitrectomy procedure.The procedure details and the patient impact was not reported.Additional information was requested.However, none has been received till date.
 
Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.10.Two opened trocar assemblies and four open trocar handle blade assemblies in a bag were received.Samples #1, #2, #3 and #4 were visually inspected and found to be nonconforming, the cannula/hub assemblies were missing from the handle blade assemblies, therefore the cannula/hub assemblies could not be dimensionally inspected.Samples #5 and #6 were visually and dimensionally inspected and were found to be conforming.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The returned samples #5 and #6 were found to be conforming, therefore a product fit issue as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.Samples #1, #2, #3 and #4 were missing the cannula/hub assemblies and could not be visually or dimensionally tested, therefore the root cause could not be determined.No action was taken as the trocar samples #5 and 6 were manufactured to specifications and samples #1, #2, #3 and #4 were missing the trocar cannula/hub assemblies.All trocar assemblies are 100% inspected for gage size.Any non-conformances found are removed from the lot and scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No further actions are required.The manufacturer internal reference number is: (b)(4).
 
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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 Key15801632
MDR Text Key305377969
Report Number1644019-2022-00947
Device Sequence Number1
Product Code LRO
UDI-Device Identifier00380657517657
UDI-Public00380657517657
Combination Product (y/n)N
Reporter Country CodeCI
PMA/PMN Number
K880961
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 04/05/2023
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 Expiration Date09/30/2023
Device Catalogue Number8065751765
Device Lot Number2525823H
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/03/2022
Initial Date FDA Received11/15/2022
Supplement Dates Manufacturer Received03/17/2023
Supplement Dates FDA Received04/05/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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