MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY, INC. HOFFMAN/AHMED MICRO-SCISSOR; OPHTHALMIC SCISSOR

Model Number DFH-0010

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

The distributor reported that the hoffman/ahmed microscissor blade broke off when the surgeon was using it during cataract surgery.The broken blade was removed from the eye.

Manufacturer Narrative

At the time of this report the device had not been returned for evaluation.

• Brand Name: HOFFMAN/AHMED MICRO-SCISSOR
• Type of Device: OPHTHALMIC SCISSOR
• Manufacturer (Section D): MICROSURGICAL TECHNOLOGY, INC.; redmond WA
• Manufacturer Contact: 8415 154th ave., n.e.; redmond, WA 98052 ; 4255560544
• MDR Report Key: 4589803
• MDR Text Key: 15902046
• Report Number: 3019924-2015-00015
• Device Sequence Number: 1
• Product Code: HNF
• Combination Product (y/n): N
• Reporter Country Code: AR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DFH-0010
• Device Catalogue Number: DFH-0010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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