MAUDE Adverse Event Report: QUEST MEDICAL, INC. STENTUBE LACRIMAL INTUBATION SET; MANUAL OPHTHALMIC SURGICAL INSTRUMENT; LACRIMAL PROBE

Model Number LIS052

Device Problem Disassembly (1168)

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

Event Date 02/10/2017

Event Type  Injury  

Manufacturer Narrative

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 materials manager of the surgery center reported that an issue was encountered with the stent tube intubation set during use.The report stated that during a procedure, one of the stent tubes "fell apart." the report stated that the surgeon had used one of the stent tubes from the box, but the other fell apart so he opened another box to obtain a third one for use.There was no information provided regarding the patient.There were no complications reported as a result of the alleged event.The set was returned to the manufacturer for evaluation.

Manufacturer Narrative

The device was returned with one end of the stent detached from the silicone tubing.A historical review of the pull forces of (b)(6) lots of this same device model manufactured from june 2016 to february 2017 was conducted.The pull forces were found to be consistent with no statistically significant anomalies noted.All samples met manufacturing specifications.Examination of the returned device using uv light confirmed the presence of the adhesive.There were no manufacturing deficiencies identified that would have resulted in the alleged issue.

• Brand Name: STENTUBE LACRIMAL INTUBATION SET
• Type of Device: MANUAL OPHTHALMIC SURGICAL INSTRUMENT; 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
• MDR Report Key: 6426350
• MDR Text Key: 70630017
• Report Number: 1649914-2017-00027
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: LIS052
• Device Lot Number: 051907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention