MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-05-09 for ANTERIOR CHAMBER CANNULA [RYCROFT] .80 X 22 MM (21GX7/8IN) 581281 manufactured by Beaver-visitec International, Inc.
[144666131]
No further patient injury information could be obtained by bvi. Bvi has concluded that this incident may be attributed to human error. No corrective action will be taken at this time. Test results from bvi indicates that no failure should occur during normal use when the cannula and syringe are properly installed based on the intended use of the product. Scientific literature is available regarding cannula-associated ocular injuries (coi), though incidences are rare, clinicians should be securely attached onto the connecting syringe.
Patient Sequence No: 1, Text Type: N, H10
[144666132]
It was alleged the cannula, "flew off syringe into patient's eye while irrigation of the corneal wound was being performed at the end of the cataract surgery. A small tear occurred. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1211998-2019-00001 |
| MDR Report Key | 8596926 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-05-09 |
| Date of Report | 2019-05-08 |
| Date of Event | 2019-04-02 |
| Date Mfgr Received | 2019-04-02 |
| Date Added to Maude | 2019-05-09 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 CITY POINT |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7819066925 |
| Manufacturer G1 | 1211998 |
| Manufacturer Street | 500 TOTTEN POND RD. 10 CITYPOINT |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02451 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANTERIOR CHAMBER CANNULA [RYCROFT] .80 X 22 MM (21GX7/8IN) |
| Generic Name | MANUAL OPHTHALMIC SURGICAL INSTRUMENT |
| Product Code | HMX |
| Date Received | 2019-05-09 |
| Model Number | NA |
| Catalog Number | 581281 |
| Lot Number | 6007422 |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-05-09 |