MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY INC. 21G HOFFMAN/AHMED HORIZONTAL SCISSOR; OPHTHALMIC SCISSOR

Model Number DHF-0005

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

The surgeon reported that the hoffman/ahmed horizontal scissor broke while being used during cataract surgery.There was no reported impact to the patient and the broken piece was removed from the eye.

Manufacturer Narrative

The scissor was returned dirty, corroded and rusted at the site of the break.

• Brand Name: 21G HOFFMAN/AHMED HORIZONTAL SCISSOR
• 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: 3899023
• MDR Text Key: 4648701
• Report Number: 3019924-2014-00016
• 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: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DHF-0005
• Device Catalogue Number: DHF-0005
• Device Lot Number: 019734
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/05/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2014
• Initial Date FDA Received: 05/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2005
• 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