MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-06-14 for WHITE STAR HIGH SPEED VIT CUTTER NGP0025 manufactured by Abbott Medical Optics.
[77617979]
(b)(6). An investigation was conducted and included a review of complaint trending, labeling, manufacturing layout, procedure review, and the material dispatching process from the warehouse. Based on the investigation performed, it was concluded that the most probable cause of the incorrect gauge size vitrectomy cutters in the pouch was human error during the material handling process. Training awareness was conducted to reinforce the importance of adequate line clearance and reconciliation steps as instructed in the current procedures/forms as an immediate correction. Other corrective and preventive actions are in the process of being implemented to address this issue. Additionally, a voluntary recall was initiated on march 30, 2017 because of the possibility that due to this human error, 20 gauge vitrectomy cutter may be found in a 25 gauge package and a 25 gauge vitrectomy cutter may be found in a 20 gauge package. Use of a vitrectomy cutter that is a different size than expected can lead to the need to alter the surgical technique, including conjunctival dissection, incision enlargement and scleral sutures. All pertinent information available to abbott medical optics has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[77617980]
A surgery center reported mislabeling of a disposable vitrectomy cutter. A brief description from the surgery center indicated they ordered size 25 gauge disposable vitrectomy cutters but upon opening the package, the actual vitrectomy cutter had size 20 gauge engraved on the device. No patient involvement reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2648035-2017-01058 |
| MDR Report Key | 6641789 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-14 |
| Date of Report | 2017-06-14 |
| Date Mfgr Received | 2017-05-26 |
| Device Manufacturer Date | 2015-06-11 |
| Date Added to Maude | 2017-06-14 |
| 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 | MS. LOURDES GUEVARA |
| Manufacturer Street | 1700 EAST ST. ANDREW PLACE |
| Manufacturer City | SANTA ANA CA 92705 |
| Manufacturer Country | US |
| Manufacturer Postal | 92705 |
| Manufacturer Phone | 7142478497 |
| Manufacturer G1 | ABBOTT MEDICAL OPTICS INC. |
| Manufacturer Street | ROAD 402 NORTH, KM 4.2 ANASCO INDUSTRIAL PARK, POB 14 |
| Manufacturer City | ANASCO PR 00610 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00610 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2020664-04/13/17B-001-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WHITE STAR HIGH SPEED VIT CUTTER |
| Generic Name | DISPOSABLE VITRECTOMY CUTTER |
| Product Code | MLZ |
| Date Received | 2017-06-14 |
| Model Number | NGP0025 |
| Lot Number | CA06182 |
| Device Expiration Date | 2018-06-11 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MEDICAL OPTICS |
| Manufacturer Address | SANTA ANA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-14 |