MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY INC MST/PACKARD A1 .7MM 12°BEND PHACO TIP, 30°; PHACOEMULSIFICATION TIP

Model Number	PT-32230-R
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The facility reported that the surgeon noticed improper ultrasound when using a phaco tip.When the tip was removed to troubleshoot the user noticed that the tip was cracked.The doctor reported similar malfunctions on two other procedures that did not result in harm to the patients.This is the second of three reports.The tip was not returned for evaluation.
Event or Problem Description
The facility reported that the surgeon noticed improper ultrasound when using a phaco tip.When the tip was removed to troubleshoot the user noticed that the tip was cracked.There was no impact to the patient.The doctor reported similar malfunctions on two other procedures that did not result in harm to the patients.This is the second of three reports.

• Brand Name: MST/PACKARD A1 .7MM 12°BEND PHACO TIP, 30°
• Common Device Name: PHACOEMULSIFICATION TIP
• Manufacturer (Section D): MICROSURGICAL TECHNOLOGY INC; 8415 154th ave ne; redmond WA 98052
• MDR Report Key: 6849556
• Report Number: 3019924-2017-00016
• Device Sequence Number: 1522287
• Product Code: HQC
• UDI-Device Identifier: 10844685004314
• UDI-Public: 10844685004314
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: PT-32230-R
• Device Catalogue Number: PT-32230-R
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1