MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-22 for STENTUBE LACRIMAL INTUBATION SET LIS052 manufactured by Quest Medical, Inc..
[70630017]
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
[70630018]
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.
Patient Sequence No: 1, Text Type: D, B5
[74921085]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649914-2017-00027 |
| MDR Report Key | 6426350 |
| Date Received | 2017-03-22 |
| Date of Report | 2017-04-25 |
| Date of Event | 2017-02-10 |
| Date Mfgr Received | 2017-02-13 |
| Device Manufacturer Date | 2016-08-19 |
| Date Added to Maude | 2017-03-22 |
| 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 | 2017-03-22 |
| Returned To Mfg | 2017-02-15 |
| Model Number | LIS052 |
| Lot Number | 051907 |
| 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 | 2017-03-22 |