MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other, report with the FDA on 2018-09-21 for BULK ANTERIOR CHAMBER CANNULA (RYCROFT), .30X22MM (30G X 7/8IN), 45 DEGREE 585738 manufactured by Beaver-visitec International, Inc.
[120990089]
Based on the investigation into this failure mode, bvi has concluded that no further corrective action to product or process is required. This appears to be an isolated incident that may be attributed to use error due to customer reported process to remove the cannula throughout the cataract procedure to refill the luer locking syringe with additional bss. Published scientific literature eye (lond). 2016 may; 30(5): 764-765 cannula-associated ocular injuries during cataract surgery: the northern england study; estimates a low 0. 009% occurrence rate of cannula-associated ocular injuries (coi) during cataract surgery. The authors summarized their survey confirmed that coi is an extremely rare yet potentially sight threatening complication that can occur during cataract surgery. They strongly advocate that all surgeons always check the cannula tightness and hold the cannula hub during an injection to minimize the risk of this potentially preventable iatrogenic complication.
Patient Sequence No: 1, Text Type: N, H10
[120990090]
Company representative reported an anterior chamber cannula (rycroft),. 30x22mm (30g x 7/8 in. ), 45 degree, "flew off" a 3 cc covidien monoject luer locking syringe included in a medline cataract pack (b)(4). Minor damage/bleeding of the iris due to the alleged cannula "popping off" or detaching during injection of balance salts solution (bss). It was reported that staff may be "rushing to get the cannula back on the syringe after refilling with bss. " there was no reported additional intervention. It was reported the entire cannula came off the luer locking syringe and there appeared to be no visible product defect to either the syringe or the cannula.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1211998-2018-00004 |
| MDR Report Key | 7897639 |
| Report Source | COMPANY REPRESENTATIVE,OTHER, |
| Date Received | 2018-09-21 |
| Date of Report | 2018-08-15 |
| Date of Event | 2018-06-29 |
| Date Mfgr Received | 2018-07-09 |
| Device Manufacturer Date | 2017-05-10 |
| Date Added to Maude | 2018-09-21 |
| 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 | MRS. ROBIN ROWE |
| Manufacturer Street | 500 TOTTEN RD. 10 CITYPOINT |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 2698065779 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BULK ANTERIOR CHAMBER CANNULA (RYCROFT), .30X22MM (30G X 7/8IN), 45 DEGREE |
| Generic Name | MANUAL OPHTHALMIC SURGICAL INSTRUMENT |
| Product Code | HMX |
| Date Received | 2018-09-21 |
| Returned To Mfg | 2018-08-02 |
| Model Number | 585738 |
| Lot Number | 3219293 |
| Device Availability | R |
| 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 | 2018-09-21 |