MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-09-24 for POLYMER I/A TIP, DISPOSABLE 8065751511 manufactured by Alcon Precision Device - Sinking Spring.
[17131776]
A customer reported burns on the tips of the irrigation/aspiration (i/a) handpiece. The tip was exchanged and the surgery was completed with no impact to the pt. Additional info was received from the customer reported that the burrs on the tips were observed under the microscope during surgery.
Patient Sequence No: 1, Text Type: D, B5
[17503930]
No samples were returned for eval for "burr on tip". No lot number was identified with this complaint; therefore, a lot history review could not be conducted. The root cause for "burr on tip" cannot be determined from this eval. All single use i/a tips are 100% visually inspected prior to their release. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523835-2013-00122 |
| MDR Report Key | 3409629 |
| Report Source | 00 |
| Date Received | 2013-09-24 |
| Date of Report | 2013-08-30 |
| Date of Event | 2013-04-19 |
| Date Mfgr Received | 2013-08-30 |
| Date Added to Maude | 2013-12-10 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CYNTHIA KAY |
| Manufacturer Street | 6201 S. FREEWAY R3-48 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152605 |
| Manufacturer G1 | ALCON PRECISION DEVICE - SINKING SPRING |
| Manufacturer Street | 714 COLUMBIA AVE. |
| Manufacturer City | SINKING SPRING PA 19608 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19608 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLYMER I/A TIP, DISPOSABLE |
| Generic Name | NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE |
| Product Code | HQR |
| Date Received | 2013-09-24 |
| Model Number | NA |
| Catalog Number | 8065751511 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON PRECISION DEVICE - SINKING SPRING |
| Manufacturer Address | 714 COLUMBIA AVE. SINKING SPRING PA 19608 US 19608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-24 |