MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY INC MST PACKER CHANG IOL CUTTER; OPHTHALMIC SCISSOR

Model Number DFH-0012

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2015

Event Type  malfunction  

Event Description

The blade of a mst packer/chang iol cutter broke off while attempting to cut an iol.The broken blade was removed from the eye and there was no impact to the patient.

Manufacturer Narrative

The device was returned for evaluation with corrosion and pitting at the site of the break which indicates poor or ineffective maintenance and cleaning of the device.

• Brand Name: MST PACKER CHANG IOL CUTTER
• Type of Device: OPHTHALMIC SCISSOR
• 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: robert may ; 8415 154th ave ne; redmond, WA 98052 ; 4255560544
• MDR Report Key: 4828943
• MDR Text Key: 5837251
• Report Number: 3019924-2015-00019
• 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: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: DFH-0012
• Device Catalogue Number: DFH-0012
• Device Lot Number: 042297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2011
• 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
• Patient Outcome(s): Other