MAUDE Adverse Event Report: QUEST MEDICAL, INC. STENTUBE LACRIMAL INTUBATION SET

Model Number	LIS052
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/04/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported an issue encountered with the lacrimal intubation tube during use.The report stated that the catheter was "slipping out of the silver (delivery tube)." the report stated the physical could not get it to stay in the tube so that it could be put into place, and that this actually occurred with two devices.As a result of the alleged issue, the physician opened a 3rd stent and tied a 7-0 silk around it so that the catheter would not slide out of the delivery tube.There were no patient complications reported as a result of the alleged issue.The device was returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Two devices were returned for evaluation.Both exhibited signs of use.Both samples passed pull force testing.The reported complaint could not be duplicated.The device history record for the lot was reviewed and no devices were rejected and no specific manufacturing yield issues were reported similar to the reported complaint condition.

• Brand Name: STENTUBE LACRIMAL INTUBATION SET
• Common Device Name: LACRIMAL INTUBATION SET
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 6840482
• Report Number: 1649914-2017-00069
• Device Sequence Number: 1141324
• Product Code: OKS
• UDI-Device Identifier: 10634624815527
• UDI-Public: 10634624815527
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K113118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2017

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
• Operator of Device: Physician
• Device Model Number: LIS052
• Device Lot Number: 0526927J02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/04/2017
• Supplement Date Received by Manufacturer: 08/04/2017
• Initial Report FDA Received Date: 09/01/2017
• Supplement Report FDA Received Date: 11/08/2017
• 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: Required Intervention