MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY INC. MST PACKER CHANG IOL CUTTER; OPHTHALMIC SCISSORS

Model Number DFH-0012

Device Problem Mechanical Jam (2983)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 03/29/2022

Event Type  Injury  

Manufacturer Narrative

The facility reported that the scissor would not close properly after explanting an iol causing wound damage when removing it from the eye.The evaluation of the returned device showed signs of being used to cut a hard object resulting in some blade damage however, the scissor actuated correctly.The report of the scissor not closing properly could not be confirmed.The patient was reported as "everything looks good" during subsequent follow up.

Event Description

During descemet's membrane endothelial keratoplasty and iol exchange, the scissor malfunctioned and caused tissue damage upon removal from the eye.

• Brand Name: MST PACKER CHANG IOL CUTTER
• 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 ; 4255560544
• MDR Report Key: 14247427
• MDR Text Key: 290371349
• Report Number: 3019924-2022-00002
• 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: Nurse
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DFH-0012
• Device Catalogue Number: DFH-0012
• Device Lot Number: 148757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other