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

Model Number LIS052

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/23/2017

Event Type  Injury  

Event Description

The surgery center reported an issue with the stentube lacrimal intubation device during use.The surgeon reported that of three (3) devices they used, they "just fell apart" during use.There was no additional details provided other than they were from the same lot.There were no patient complications reported as a result of the alleged issue.The actual devices were not returned for evaluation; however, one remaining device from the same lot was returned to the manufacturer.

• Brand Name: STENTUBE LACRIMAL INTUBATION SET
• Type of Device: LACRIMAL INTUBATION SET
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• Manufacturer (Section G): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• Manufacturer Contact: amy clendening-wheeler ; one allentown parkway; allen, TX 75002
• MDR Report Key: 6656085
• MDR Text Key: 78020197
• Report Number: 1649914-2017-00049
• Device Sequence Number: 1
• Product Code: OKS
• UDI-Device Identifier: 10634624815527
• UDI-Public: 10634624815527
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/23/2017

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
• Device Operator: Physician
• Device Model Number: LIS052
• Device Lot Number: 052858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2017
• Initial Date Manufacturer Received: 05/23/2017
• Initial Date FDA Received: 06/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention