MST NOT APPLICABLE UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-11-24 for MST NOT APPLICABLE UNK manufactured by Microsurgical Technology, Inc..

Event Text Entries

[16179900] Patient underwent cataract removal with toric iol implantation on (b)(6) 2014. First day post op eye exam was normal. On one week post-operative examination with use of the slit lamp and with the eye dilated, a small cylinder shaped piece of metal was identified near the lens. The patient's eye exam was otherwise normal and she denied visual difficulties. The patient underwent outpatient surgery on (b)(6) 2014 to remove the metal fragment without difficulty. After removal, examination of the metal fragment under microscope, showed that it was part of the tip for the mandelburg irrigating rotator which is used when implanting a toric iol and was used on this patient a week ago. Key points that link the metal piece to the device are the following: the mandelburg irrigating rotator when tested on (b)(6) 2014 did not function as per usual. It only irrigated out of the end of the device rather than through the two side ports. The size/diameter of the metal object exactly matched the size/diameter of the end of the mandelburg irrigating rotator. The metal object was the same blue color as the mandelburg irrigating rotator tip.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5039305
• MDR Report Key: 4284327
• Date Received: 2014-11-24
• Date of Report: 2014-11-12
• Date of Event: 2014-01-11
• Date Added to Maude: 2014-12-01
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MST
• Generic Name: MANDELBURG IRRIGATING ROTATOR
• Product Code: HNI
• Date Received: 2014-11-24
• Model Number: NOT APPLICABLE
• Catalog Number: UNK
• Lot Number: NOT APPLICABLE
• ID Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MICROSURGICAL TECHNOLOGY, INC.
• Manufacturer Address: REDMOND WA US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-11-24