MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-12-19 for SOFT TIP CANNULA, 25G 587003 manufactured by Beaver-visitec, International, Inc.
[130791106]
This report has been submitted on wed nov 14 23:46:22 est 2018 form 3500a through esg production system. This report is being resubmitted with updated information.
Patient Sequence No: 1, Text Type: N, H10
[130791107]
A soft tip cannula designed for vitreoretinal procedures has a silicon tip. A fragment of the silicon tip "fell off" intraocular during a vitreoretinal procedure. The surgeon was able to retrieve the fragment of silicon using a vitrectomy device. The silicon tip was removed without injury to the patient's eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1211998-2018-00005 |
| MDR Report Key | 8178735 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-12-19 |
| Date of Report | 2018-12-18 |
| Date of Event | 2018-10-11 |
| Date Mfgr Received | 2018-11-10 |
| Date Added to Maude | 2018-12-19 |
| 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 | MR. GENCI OMARI |
| Manufacturer Street | 500 TOTTEN POND RD 10 CITYPOINT |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7819066925 |
| Manufacturer G1 | BEAVER-VISITEC INTERNATIONAL, INC |
| Manufacturer Street | 500 TOTTEN POND RD 10 CITYPOINT |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02451 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 1211998-11/26/2018-004-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOFT TIP CANNULA, 25G |
| Generic Name | MANUAL OPHTHALMIC SURGICAL INSTRUMENT. CANNULA, OPHTHALMIC |
| Product Code | HMX |
| Date Received | 2018-12-19 |
| Returned To Mfg | 2018-10-23 |
| Catalog Number | 587003 |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BEAVER-VISITEC, INTERNATIONAL, INC |
| Manufacturer Address | 500 TOTTEN POND RD 10 CITYPOINT WALTHAM MA 02451 US 02451 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2018-12-19 |