MAUDE Adverse Event Report: SYNERGETICS ONE STEP CANNULA; OPHTHALMIC CANNULA

Model Number 58.23

Device Problems Break (1069); Component Falling (1105)

Patient Problem No Code Available (3191)

Event Date 07/06/2016

Event Type  Injury  

Manufacturer Narrative

Cannula is broken in middle of polyimide tubing with sharp fracture.Glue joint and hub are fully intact.Fracture on yellow polyimide tube appears that an instrument caught the cannula causing the cannula to tear.Failure is not systemic and is not caused by any manufacturing defect.This failure was caused by user damage during surgery.Reviewed manufacturing batch records and found not anomalies.This is the only failure of this type this year which indicates a less than 1 in 5000 failure rate.Failure is not systemic and is not a manufacturing defect.Failure was caused by damage during surgery.Polyimide tubing is plastic and damage during surgery is possible.

Event Description

A trocar broke during surgery and fell into the vitreous.An unplanned second surgery was required to remove the trocar piece.

• Brand Name: ONE STEP CANNULA
• Type of Device: OPHTHALMIC CANNULA
• Manufacturer (Section D): SYNERGETICS; 3845 corporate centre drive; o fallon MO 63368
• Manufacturer (Section G): SYNERGETICS; 3845 corporate centre drive; o fallon MO 63369
• Manufacturer Contact: dan regan ; 3845 corporate centre drive; o fallon, MO 63369 ; 6367945013
• MDR Report Key: 7177519
• MDR Text Key: 96813317
• Report Number: 1932402-2018-00001
• Device Sequence Number: 1
• Product Code: NGY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2018
• Device Model Number: 58.23
• Device Catalogue Number: 58.23
• Device Lot Number: M548780
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/07/2016
• Initial Date FDA Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention