MAUDE Adverse Event Report: KATENA PRODUCTS, INC; NAGAHARA PHACO CHOPPER

Model Number	08-14502
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned instrument was visually inspected under a microscope and compared to the master model.There is no evidence of material defect or manufacturing error.No similar complaints have been received for the device.The instrument appears to have been damaged prior to breaking.The cause of instrument tip breakage could not be determined because the broken tip was not retuned for evaluation.The user facility indicated that there was no injury to the patient.After the tip broke off, the surgeon immediately retrieved the tip from patient's eye with no complications.No prolonged surgery or hospitalization was required.The patient's post-op visit the following day went well, no complaints or complications reported, and no further recommendations.
Event or Problem Description
During a cataract extraction with iol implant procedure the tip of the nagahara phaco chopper broke off in the patient's eye.The surgeon immediately retrieved the tip with no complications and no injury to the patient was reported.No prolonged surgery or hospitalization was required.The patient's post-op visit the following day went well, no complaints or complications reported.

• Brand Name: KATENA PRODUCTS, INC
• Common Device Name: NAGAHARA PHACO CHOPPER
• MDR Report Key: 11641011
• Report Number: 2242450-2021-00001
• Device Sequence Number: 3052387
• Product Code: HNQ
• UDI-Device Identifier: 00852979003304
• UDI-Public: 00852979003304
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/09/2021

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
• Operator of Device: Health Professional
• Device Model Number: 08-14502
• Device Catalogue Number: 08-14502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 04/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention