MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-07-21 for LARGE DIAMETER LACRIMAL INTUBATION SET/ STENTUBE LIS052 * manufactured by Quest Medical, Inc..
[15612368]
The customer reported that during the procedure, the doctor inserted the wire and pulled it with a hook to bring the stentube through and both tubes separated from the wire. The or tech reported that they have been lubricating the thick portion of the stentube to help slide it through but it still breaks. During this particular incident, both tubes broke and the procedure was completed using another device. The samples were saved and will be returned to quest. Product code lis052, lot numbers 22402. 01m and 22404. 01m.
Patient Sequence No: 1, Text Type: D, B5
[15988051]
H3: potential root cause determined; currently working on corrective action. Add'l lot # 22404. 01m, expiration date 9/2/2006.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649914-2006-00059 |
| MDR Report Key | 742084 |
| Report Source | 05,06 |
| Date Received | 2006-07-21 |
| Date of Report | 2006-07-21 |
| Date Mfgr Received | 2006-06-15 |
| Device Manufacturer Date | 2004-09-01 |
| Date Added to Maude | 2006-08-01 |
| 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 | 0 |
| Manufacturer Contact | MEGAN SIMS |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal | 75002 |
| Manufacturer Phone | 9723909800 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LARGE DIAMETER LACRIMAL INTUBATION SET/ STENTUBE |
| Generic Name | MANUAL OPHTHALMIC SURGICAL INSTRUMENT: LACRYMAL PROBE |
| Product Code | HNW |
| Date Received | 2006-07-21 |
| Returned To Mfg | 2006-07-06 |
| Model Number | LIS052 |
| Catalog Number | * |
| Lot Number | 22402.01M |
| ID Number | * |
| Device Expiration Date | 2006-01-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 729923 |
| Manufacturer | QUEST MEDICAL, INC. |
| Manufacturer Address | ONE ALLENTOWN PKWY ALLEN TX 75002 US |
| Baseline Brand Name | STENTUBE |
| Baseline Generic Name | OPHTHALMIC INTUBATION TUBE |
| Baseline Model No | LIS052 |
| Baseline Catalog No | LIS052 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-07-21 |