MAUDE Adverse Event Report: KANEKA CORPORATION LACRIFAST; LACRIMAL STENTS AND INTUBATION SETS

Model Number	LF-R090A
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual device used was returned and investigated: there was a hole, from where the bougie was thought to penetrate out, in the distal tip of the tube (colored in clear) where a stainless steel ring was mounted, and the ring was dismounted and missing.The ring's whereabouts was not confirmed during the procedure in this eye clinic, and accordingly, it has a possibility that the missing stainless steel ring might have been remaining in the patient body.As a possible cause of the penetration of the bougie and dropping off the ring during the use, we speculate as follows: when the doctor tried to insert and advance the tube with the bougie inserted forcibly in the occluded lacrimal duct, excessive mechanical force was loaded on the ring and the distal tip of the tube where the ring was mounted, and further pushing the bougie resulted in dismounting the ring and penetration of the bougie with the ring out of the tube.
Event or Problem Description
The doctor felt the bougie pierced through the tube as she advanced the lacrimal tube.She recovered the lacrimal tube from the patient's lacrimal duct and found that it had a hole.When the actual device used was investigated, the ring was dismounted and missing.The ring's whereabouts was not confirmed during the procedure in this eye clinic, and accordingly, it has a possibility that the missing stainless steel ring might have been remaining in the patient body.This device is the same device as the us name lacriflow (510 (k) # k120886).

• Brand Name: LACRIFAST
• Common Device Name: LACRIMAL STENTS AND INTUBATION SETS
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima, kita-ku; osaka, osaka 53082 88; JA 5308288
• MDR Report Key: 12005913
• Report Number: 3009761573-2021-00002
• Device Sequence Number: 3096667
• Product Code: OKS
• UDI-Device Identifier: 04540778140875
• UDI-Public: 04540778140875
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: LF-R090A
• Device Catalogue Number: LF2-R090
• Device Lot Number: KR011366
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 06/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 85 YR