MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY INC 23G HOFFMAN/AHMED MICRO-SCISSORS; OPHTHALMIC SCISSOR

Model Number DFH-0010

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was returned showing signs of heavy use.The internal components were corroded and dirty.

Event Description

The facility reported that a mst scissor had broken in the patient's eye during cataract surgery.There was no impact to the patient.

• Brand Name: 23G HOFFMAN/AHMED MICRO-SCISSORS
• 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: 5760670
• MDR Text Key: 49237639
• Report Number: 3019924-2016-00015
• 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: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: DFH-0010
• Device Catalogue Number: DFH-0010
• Device Lot Number: 045576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2012
• 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