MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-23 for STENTUBE LACRIMAL INTUBATION SET LIS052 manufactured by Quest Medical, Inc..
[71044622]
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.
Patient Sequence No: 1, Text Type: N, H10
[71044623]
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.
Patient Sequence No: 1, Text Type: D, B5
[74842259]
(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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649914-2017-00019 |
| MDR Report Key | 6428414 |
| Date Received | 2017-03-23 |
| Date of Report | 2017-04-21 |
| Date of Event | 2017-02-21 |
| Date Mfgr Received | 2017-02-21 |
| Date Added to Maude | 2017-03-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. AMY CLENDENING-WHEELER |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal | 75002 |
| Manufacturer G1 | QUEST MEDICAL, INC. |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STENTUBE LACRIMAL INTUBATION SET |
| Generic Name | MANUAL OPHTHALMIC SURGICAL INSTRUMENT; LACRIMAL PROBE |
| Product Code | OKS |
| Date Received | 2017-03-23 |
| Returned To Mfg | 2017-03-27 |
| Model Number | LIS052 |
| Lot Number | 052703 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUEST MEDICAL, INC. |
| Manufacturer Address | ONE ALLENTOWN PARKWAY ALLEN TX 75002 US 75002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-03-23 |