MAUDE Adverse Event Report: FCI S A S FCI 20 22 LACRIMAL TUBE; LACRIMAL STENTS AND INTUBATION SETS

Model Number SELF-THREADING MONOKA WIDE COLLARETTE FAYET, BERNARD, RITLENG

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/05/2021

Event Type  malfunction  

Event Description

Patient scheduled for outpatient surgery (bilateral probing of lacrimal ducts with possible tube insertion).When inserting the tube in the right lacrimal duct, the guiding portion of the tube broke off during the threading of the tube.(vendor fci ref s1.1800u self-threading monoka wide collarette lot 1853670).Surgeon notified scrub tech and circulator of incident.Surgeon visualized superficially with a sinuscope to see if he could find the broken portion.When he was unable to, he contacted ent (ear, nose and throat).Ent arrived and performed a bilateral nasal endoscopy and direct laryngoscopy/bronchoscopy and was unable to locate the broken portion.Consulted gi (gastrointestinal) to see if piece had moved to esophagus.Gi performed an egd (esophagogastroduodenoscopy), broken portion still not found.Black wire is guidewire, and this is a portion that broke off, the clear is the tube that was going to be inserted, the metal piece is the or lacrimal probe.Comment made "he believes the lacrimal probe might have caused the breakage because he felt resistance when he attempted to retract.When he retracted, he felt it pop and that's how he knows a piece broke off.".

• Brand Name: LACRIMAL TUBE
• Type of Device: LACRIMAL STENTS AND INTUBATION SETS
• Manufacturer (Section D): FCI S A S FCI 20 22; 3308 jefferson ave; cincinnati OH 45220
• MDR Report Key: 13590702
• MDR Text Key: 286058824
• Report Number: 13590702
• Device Sequence Number: 1
• Product Code: OKS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SELF-THREADING MONOKA WIDE COLLARETTE FAYET, BERNARD, RITLENG
• Device Catalogue Number: S1.1800U
• Device Lot Number: 1853670
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/16/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 365 DA
• Patient Sex: Female