ONE-STEP CANNULA 58.23S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-07-20 for ONE-STEP CANNULA 58.23S manufactured by Synergetics.

Event Text Entries

[2503678] Surgeon used a 23 gauge blade to perform the sclerotomy and discovered intraoperatively that the blade was missing.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1932402-2011-00004
• MDR Report Key: 2370372
• Report Source: 07
• Date Received: 2011-07-20
• Date of Report: 2011-07-15
• Date of Event: 2011-06-22
• Date Mfgr Received: 2011-06-22
• Date Added to Maude: 2012-06-11
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: DAN REGAN
• Manufacturer Street: 3845 CORPORATE CENTRE DR.
• Manufacturer City: O'FALLON MO 63368
• Manufacturer Country: US
• Manufacturer Postal: 63368
• Manufacturer Phone: 6367945013
• Manufacturer G1: SYNERGETICS
• Manufacturer Street: 3845 CORPORATE CENTRE DR.
• Manufacturer City: O'FALLON MO 63368
• Manufacturer Country: US
• Manufacturer Postal Code: 63368
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ONE-STEP CANNULA
• Generic Name: 23 GAUGE BLADE, PRODUCT CODE: NGY
• Product Code: HQB
• Date Received: 2011-07-20
• Model Number: 58.23S
• Catalog Number: 58.23S
• Lot Number: NOT KNOWN
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SYNERGETICS
• Manufacturer Address: 3845 CORPORATE CENTRE DR. O'FALLON MO 63368 US 63368

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2011-07-20