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

Model Number DFH-0012

Device Problem Noise, Audible (3273)

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

Event Date 01/20/2017

Event Type  malfunction  

Manufacturer Narrative

The device was returned dirty and corroded.The cannula of the scissor was cracked and rusted.The malfunction was due to improper cleaning and maintenance.There was no impact to the patient.

Event Description

During surgery the surgeon noted hearing a snapping sound coming from the scissors.The surgeon discontinued use of the device and there was no impact to the patient.

• Brand Name: 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: john ray ; 8415 154th ave ne; redmond, WA 98052 ; 4255560544
• MDR Report Key: 6347811
• MDR Text Key: 68223639
• Report Number: 3019924-2017-00003
• 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 faci
• Reporter Occupation: Nurse
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2017
• 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: 064410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1