MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY, INC. PACKER/CHANG IOL CUTTER; OPHTHALMIC SCISSOR

Model Number DFH-0012

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The surgeon reported that the packer chang iol cutter broke when he attempted to cut an iol.There was no impact to the patient and the broken piece was removed from the eye.

Manufacturer Narrative

The device was returned for evaluation dirty, rusty and corroded in a way that suggest the device was not properly cleaned and maintained according to the directions for use.

• Brand Name: PACKER/CHANG IOL CUTTER
• Type of Device: OPHTHALMIC SCISSOR
• Manufacturer (Section D): MICROSURGICAL TECHNOLOGY, INC.; redmond WA
• Manufacturer Contact: 8415 154th ave., n.e.; redmond, WA 98052 ; 4255560544
• MDR Report Key: 3793140
• MDR Text Key: 4476669
• Report Number: 3019924-2014-00002
• Device Sequence Number: 1
• Product Code: HNF
• Combination Product (y/n): N
• Reporter Country Code: AR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DFH-0012
• Device Catalogue Number: DFH-0012
• Device Lot Number: 040676
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/19/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2011
• 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