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 Date 06/19/2014

Event Type  malfunction  

Event Description

The facility reported that the packer/chang iol scissor broke during surgery in the patient's eye.The broken piece of the scissor was removed and there was no impact to the patient.

Manufacturer Narrative

The scissor was returned dirty and corroded at the site of the break indicating it had not been maintained adequately per the instructions 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 ne; redmond, WA 98052 ; 4255560544
• MDR Report Key: 4156875
• MDR Text Key: 19721759
• Report Number: 3019924-2014-00026
• Device Sequence Number: 1
• Product Code: HNF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2014
• 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: 040298
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/15/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2011
• 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