MAUDE Adverse Event Report: QUEST MEDICAL, INC. LACRIMAL INTUBATION SET, CRAWFORD TYPE; LACRIMAL PROBE

Model Number LIS27T

Device Problem Material Deformation (2976)

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

Event Date 05/10/2016

Event Type  malfunction  

Manufacturer Narrative

Although the customer did not report a lot # of the involved product, the returned samples were in a box with lot id of 60103c.The device history records for lot # 60103cc were reviewed, the inspection report showed that no devices were rejected and no specific manufacturing yield issues were reported to the complaint condition inspection of the samples indicate that the samples have been used, the steel used for this device is soft but firm enough.While the device is designed to provide ease of placement and enhanced stenting effect in post dcr procedures to prevent postoperative prolapse the pliability of the product is needed to maneuver the device through hard anatomical structures.As the steel probes are very thin, they bend if hit against the bony prominences, therefore, depending upon the surgeon preference, the puncta and the canaliculi may or may not be dilated before the placement of the device but is not required.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 Description

The international distributor (b)(6) reported an issue encountered by one of their customers while using the device.The report stated that the stainless steel was too soft, that it was not easy to intubate, and that it was deformed.Despite multiple requests to the distributor for additional information there was none provided.The device was returned to the manufacturer for evaluation.

• Brand Name: LACRIMAL INTUBATION SET, CRAWFORD TYPE
• Type of Device: LACRIMAL PROBE
• 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 ; 9723326338
• MDR Report Key: 5698992
• MDR Text Key: 47798447
• Report Number: 1649914-2016-00027
• Device Sequence Number: 1
• Product Code: HNL
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/02/2021
• Device Model Number: LIS27T
• Device Lot Number: 60103CC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention