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)
Date of Event	08/08/2017
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 first of three reports the phaco tip returned for evaluation was bent and crack.The tip showed signs of coming into contact with something hard, most likely another device.This is thought to have contributed to the cracking in the tip.
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 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 first 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: 6849541
• Report Number: 3019924-2017-00015
• Device Sequence Number: 65273
• 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 Expiration Date: 05/01/2021
• Device Model Number: PT-32230-R
• Device Catalogue Number: PT-32230-R
• Device Lot Number: 073701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• 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