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

Model Number	LIS052
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Attempts to obtain the device for evaluation from the complainant are on-going.Quest medical, inc.Has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Quest medical, inc.Defers to the patient's physician regarding medical history.
Event or Problem Description
The hospital purchasing department reported an issue encountered by the physician while using the lacrimal intubation set.The report stated that pieces of the device broke into the patient's eye while the physician was inserting it during a right endoscopic dacryoadenotomy.The report stated the surgical site was examined to retrieve the broken pieces and another device was used to complete the procedure.There were no patient complications reported as a result of the alleged event.It is unknown if the device will be returned for evaluation; it is with the hospital's clinical engineering department.
Additional Manufacturer Narrative
The device was not returned for evaluation.The device history records were reviewed and the inspection report showed that no devices were rejected and no specific manufacturing yield issues were reported similar to the complaint condition.The inspection data did not show any non-conformancies or anomalies for the incoming material components for the tube or the shrink tubing.

• Brand Name: STENTUBE LACRIMAL INTUBATION SET
• Common Device Name: LACRIMAL STENT AND INTUBATION SET
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 5746348
• Report Number: 1649914-2016-00031
• Device Sequence Number: 623204
• Product Code: OKS
• UDI-Device Identifier: 10634624815527
• UDI-Public: 10634624815527
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K113118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2016

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: Physician
• Device Expiration Date: 08/23/2018
• Device Model Number: LIS052
• Device Lot Number: 0497825G08
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/23/2016
• Supplement Report FDA Received Date: 07/25/2016
• 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