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

Model Number DFH-0008

Device Problem Inadequate or Insufficient Training (1643)

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

Event Type  malfunction  

Manufacturer Narrative

The device evaluation showed that the blade was broken off from the top of the tine, the other blade broke at the base of the tine.There was moderate corrosion at the site of the fractures and throughout the cannula of the scissors.Small rust spots visible and corrosion pits.The mouth of the cannula is deformed, flared where the tines had made contact, indicating that scissors came into contact with hard object.Device failure is due to corrosion and inadequate use, these scissors are not made to cut the iol due to how hard the iol is.

Event Description

The customer reported the blade was caught in the iol and fell off in the eye during cataract surgery.The blade and iol was removed during surgery and no known harm to the patient.

• Brand Name: HOFFMAN/AHMED HORIZONTAL MICRO-SCISSORS, CURVED, 23 GAUGE
• Type of Device: OPHTHALMIC SCISSORS
• 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: cecil chrisinger ; 8415 154th ave ne; redmond, WA 98052
• MDR Report Key: 7684111
• MDR Text Key: 114056024
• Report Number: 3019924-2018-00024
• Device Sequence Number: 1
• Product Code: HNF
• UDI-Device Identifier: 00084468500128
• UDI-Public: 0084468500128
• 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
• Type of Report: Initial
• Report Date: 07/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DFH-0008
• Device Catalogue Number: DFH-0008
• Device Lot Number: 045617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/29/2012
• 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
• Patient Outcome(s): Other