MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY INC HOFFMAN/AHMED HORIZONTAL MICRO-SCISSORS, CURVED, 23 GAUGE WITH INSPECTION PORT; OPHTHALMIC SCISSOR

Model Number DFH-0008

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device evaluation showed that the scissor was used to cut to hard of an object, an iol.This scissor is indicated to cut soft tissue and objects in the eye per the dfu.

Event Description

Ophthalmic scissor blade broke in the eye while cutting a lens.The blade was removed without issue and there was no patient impact.

• Brand Name: HOFFMAN/AHMED HORIZONTAL MICRO-SCISSORS, CURVED, 23 GAUGE WITH INSPECTION PORT
• 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: 5556336
• MDR Text Key: 42681086
• Report Number: 3019924-2016-00003
• 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: Medical Assistant
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: DFH-0008
• Device Catalogue Number: DFH-0008
• Device Lot Number: 045283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2012
• 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