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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON ALCON; 27 GAUGE SOFT TIP CANNULA, 0.8 MM
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ALCON ALCON; 27 GAUGE SOFT TIP CANNULA, 0.8 MM Back to Search Results
Lot Number 998255M
Device Problem Material Fragmentation (1261)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/16/2017
Event Type  Injury  
Event Description
A 27 gauge soft tip cannula, 0.8 mm was requested for case.Dr placed trocars into eye and inserted soft tip cannula.Operation commenced and soft tip was removed from eye.At that time it was noticed that tip was missing but could not be located.Another soft tip was retrieved and introduced through trocar.At this time the tip to the cannula was seen floating inside the eye.It is thought that the tip loose and lodged inside the trocar.Introduction of the second soft tip pushed the loose tip into the eye.A 27 gauge max grip force was used to remove the loose cannula tip from the eye.There was no impact to pt other than delay of case.Diagnosis or reason for use: pars plana vitrectomy endolaser, cryo, air-fluid exchange.(b)(6).
 
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Brand Name
ALCON
Type of Device
27 GAUGE SOFT TIP CANNULA, 0.8 MM
Manufacturer (Section D)
ALCON
MDR Report Key7071501
MDR Text Key93442400
Report NumberMW5073647
Device Sequence Number1
Product Code NGY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/20/2017
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 Lot Number998255M
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/30/2017
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age52 YR
Patient Weight83
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