MAUDE Adverse Event Report: KATENA PRODUCTS, INC. RHEIN, CONNOR WAND STRAIGHT; SPATULA, OPHTHALMIC

Model Number 08-07114

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2021

Event Type  malfunction  

Event Description

During left cataract surgery, the end of instrument broke off.No harm to patient another tray was opened and used.A new connor wand was ordered.

• Brand Name: RHEIN, CONNOR WAND STRAIGHT
• Type of Device: SPATULA, OPHTHALMIC
• Manufacturer (Section D): KATENA PRODUCTS, INC.; 123 cliff cave road; saint louis MO 63129
• MDR Report Key: 12719214
• MDR Text Key: 279089384
• Report Number: 12719214
• Device Sequence Number: 1
• Product Code: HNC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 08-07114
• Device Catalogue Number: 08-07114
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/21/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25185 DA
• Patient Weight: 27