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

Model Number LIS052

Device Problems Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

Patient Problems Hemorrhage/Bleeding (1888); Foreign Body In Patient (2687)

Event Date 07/31/2018

Event Type  malfunction  

Manufacturer Narrative

The device has not been received for evaluation and no additional information has been received with respect to patient impact.A follow up medwatch will be submitted if additional information is received.

Event Description

A report was received regarding an alleged issue encountered during use of the lacrimal intubation set.The report states that the surgeon removed a stentube that was in pieces from a tear duct.The patient had bleeding in the tear duct after placing stentube in the eye and they found an actual piece of the stentube in the tear duct.

Manufacturer Narrative

The complaint sample was not returned for evaluation.A dhr review was conducted and no anomalies were found.Quest medical is not privy to information on the patient's medical or physiological conditions or surgical technique employed by the surgeon.No additional information has been provided by the facility on events surrounding the incident.Based on a review of manufacturing records, the root cause of this incident is not manufacturing related.Quest medical is unable to confirm the root cause of the reported incident.Complaints will continue to be monitored for trending.

Event Description

The medwatch filed by the user facility on this incident states that "the patient has had a probe and stent procedure done twice for persistent tearing, developed persistent bloody tears, not improved with steroid eye drops.Patient ultimately taken to the operating room (or) and on exploration of the lacrimal sac, there was a plastic fragment from a stent tube found in the lacrimal sac.Patient has received two sets of stents from two surgical events-one in (b)(6) 2017.Child pulled the stents placed in (b)(6) 2017 out herself.".

• 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: tosan onosode ; one allentown parkway; allen, TX 75002 ; 9723326338
• MDR Report Key: 7838578
• MDR Text Key: 119494832
• Report Number: 1649914-2018-00076
• Device Sequence Number: 1
• Product Code: OKS
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LIS052
• Device Catalogue Number: 801008
• Device Lot Number: 0509836M03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention