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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 8065752022
Device Problem Gas/Air Leak (2946)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/20/2020
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 that air leakage caused actuation failure in the probe during vitreous procedure.The condition of aspiration is unknown.The product was replaced and procedure completed with no patient harm.
 
Manufacturer Narrative
Additional information provided in d.10., 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.One opened probe was received with a tip protector, in a bubble bag along with other items, for the report of air leakage caused actuation failure.The returned sample was visually inspected and found to be non-conforming with orange/brown foreign material on the port.The sample was then functionally tested for actuation, aspiration, and cut.The sample was found to be conforming for cut and aspiration, with no bubbles observed, and was found non-conforming for actuation.The probe sample was disassembled and the components inspected.No/minimal wear was observed on the inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.No wear marks were observed along the inner cutter.The sample was retested for actuation with the probe driver and was able to actuate.The initial actuation test failed due to an interference within the probe and once the interference (needle assembly) was removed the probe was able to actuate.The complaint evaluation does not confirm that the probe had air leakage, however, the evaluation confirms the probe sample had an actuation failure.The exact cause for the actuation failure cannot be determined from the evaluation performed.No specific action with regard to this complaint was taken by the manufacturing site because the probe sample did not show air leakage and the exact root cause for the observed actuation failure is unknown.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Complaints will be continued to be reviewed and monitored at regular intervals for any significant adverse trends.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
MDR Report Key10414096
MDR Text Key203711822
Report Number1644019-2020-00434
Device Sequence Number1
Product Code LRO
Combination Product (y/n)N
PMA/PMN Number
K880961
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 11/05/2020
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 Date07/31/2021
Device Catalogue Number8065752022
Device Lot Number2314159H
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/16/2020
Initial Date Manufacturer Received 08/03/2020
Initial Date FDA Received08/17/2020
Supplement Dates Manufacturer Received11/02/2020
Supplement Dates FDA Received11/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CONSTELLATION LXT JAPAN
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