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

Model Number	LIS052
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer has indicated the samples will be returned for evaluation; however, they have not yet been returned.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 user facility notified the manufacturer that they have had multiple failures of the model lis052 stent tubes.They stated they had received 6 boxes (2 intubation tubes per box) but the first 3-4 boxes failed due to "literally falling apart" with the silicone was coming off as the surgeon tried to place them during the procedures.No specific details regarding any of the procedures or patients was provided; however, there was no mention of any patient complications as a result of the alleged events stated in the original report.Attempts to obtain additional information from user facility have not been successful.User facility indicated they were returning a sample for evaluation but no samples have been returned as of the date of this report.
Additional Manufacturer Narrative
(b)(6) unused samples were returned for evaluation.(b)(6) devices passed the inspection criterial including meeting the maximum peak load for 1lb.A historical review of the pull forces of (b)(6) lots of this same device model manufactured from (b)(6) 2016 to (b)(6) 2017 was conducted and 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
• Common Device Name: MANUAL OPHTHALMIC SURGICAL INSTRUMENT; LACRIMAL PROBE
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 6428414
• Report Number: 1649914-2017-00019
• Device Sequence Number: 13532314
• Product Code: OKS
• UDI-Device Identifier: 10634624815527
• UDI-Public: 10634624815527
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/21/2017

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
• Operator of Device: Physician
• Device Model Number: LIS052
• Device Lot Number: 052703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/21/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/23/2017
• Supplement Report FDA Received Date: 05/02/2017
• 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