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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FCI OPHTHALMIC RITLENG; LACRIMAL STENTS AND INTUBATION SETS
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FCI OPHTHALMIC RITLENG; LACRIMAL STENTS AND INTUBATION SETS Back to Search Results
Model Number S1-1460
Device Problems Break (1069); Entrapment of Device (1212); Failure to Advance (2524)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/07/2021
Event Type  malfunction  
Event Description
The inferior puncta was dilated with the sharp dilator.The fci guide was then passed through the lower system, while turning the guide it was noticed that it didn't go down, the guider was then withdrawn, and it was noticed that the tip was broken off.The tip was still in the lacrimal system.X-ray was then performed.It confirmed that the tip was still in the lacrimal duct system.Phone consult was performed with dr.Who recommended removal of the foreign body.Discussed events and plan with parent.Arranged for removal today.The patient was awakened in the operating room and taken to the recovery room in good condition.
 
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Brand Name
RITLENG
Type of Device
LACRIMAL STENTS AND INTUBATION SETS
Manufacturer (Section D)
FCI OPHTHALMIC
30 corporate park drive,suite #310/320
pembroke MA 02359
MDR Report Key12092072
MDR Text Key259157686
Report Number12092072
Device Sequence Number1
Product Code OKS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberS1-1460
Device Catalogue NumberS1-1460
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/07/2021
Event Location Hospital
Date Report to Manufacturer06/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age365 DA
Patient Weight10
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