MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a *,00 report with the FDA on 2014-01-31 for AVE ADAPTABLE VIT ENHANCER 6200AE manufactured by Abbott Medical Optics.
[4091809]
It was reported that surgeon experienced a communication failure with the equipment during a vitrectomy procedure, and the operation stopped for approximately 30 minutes. This issue happened after the start of surgery (incision was made). The surgeon exchanged to a new vitrectomy cutter (the one he was using was 30 months old) and completed the operation. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[11488905]
(b)(4):device has not been received for evaluation. All pertinent information available to abbott medical optics has been submitted. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
[11655043]
Patient Sequence No: 1, Text Type: N, H10
[12073202]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[27006076]
The initial report incorrectly stated that the vitrectomy cutter customer was using was 30 months old. Information was recently corrected and age of device was not provided. The surgeon replaced the vitrectomy cutter after the 30 minute delay.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020664-2014-00006 |
| MDR Report Key | 3601955 |
| Report Source | *,00 |
| Date Received | 2014-01-31 |
| Date of Report | 2014-01-09 |
| Date of Event | 2014-01-09 |
| Date Mfgr Received | 2014-08-04 |
| Device Manufacturer Date | 2008-01-15 |
| Date Added to Maude | 2014-01-31 |
| 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 | MRS. VALERIE SEDZICKI |
| Manufacturer Street | 1700 EAST ST. ANDREW PLACE |
| Manufacturer City | SANTA ANA CA 92705 |
| Manufacturer Country | US |
| Manufacturer Postal | 92705 |
| Manufacturer Phone | 7142478567 |
| Manufacturer G1 | ABBOTT MEDICAL OPTICS INC. |
| Manufacturer Street | 557 MCCORMICK STREET |
| Manufacturer City | SAN LEANDRO CA 94577 |
| Manufacturer Postal Code | 94577 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AVE ADAPTABLE VIT ENHANCER |
| Generic Name | PHACO ACCESSORIES |
| Product Code | MLZ |
| Date Received | 2014-01-31 |
| Model Number | 6200AE |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| 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 | 1. Other | 2014-01-31 |