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

Model Number PT-33230-R

Device Problems Contamination /Decontamination Problem (2895); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem Intraocular Infection (1933)

Event Date 04/05/2018

Event Type  Injury  

Manufacturer Narrative

Mst was notified of a reported tass incident involving a phaco tip.The physician later explained that the facility was not tracking how many uses the phaco tip was undergoing nor was the facility flushing that handpieces well after each use.The combination of these maintenance issues may lead to an infection.

Event Description

A phaco tip was involved with a surgery where there was a reported incident of tass.

• Brand Name: MST/PACKARD A1 .7MM BENT DEWEY 30°
• Type of Device: PHACOEMULSIFICATION TIP
• Manufacturer (Section D): MICROSURGICAL TECHNOLOGY, INC.; 8415 154th ave ne; redmond WA 98052
• Manufacturer (Section G): MICROSURGICAL TECHNOLOGY, INC.; 8415 154th ave ne; redmond WA 98052
• Manufacturer Contact: rob raney ; 8415 154th ave ne; redmond, WA 98052 ; 4255560544
• MDR Report Key: 7503474
• MDR Text Key: 107887280
• Report Number: 3019924-2018-00016
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: PT-33230-R
• Device Catalogue Number: PT-33230-R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other