MAUDE Adverse Event Report: MED-LOGICS, INC. CALIBRATED LASIX BLADE (CLB) ML7070; MICROKERATOME BLADE

Model Number ML7070

Device Problem Out-Of-Box Failure (2311)

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

Event Date 05/21/2015

Event Type  malfunction  

Event Description

Physician noticed the blade was extended too far out of the head.Blade was not used on patient.Physician opened another blade and was able to push the white plastic blade holder right off the blade with little to no effort.He then opened three more blades from the same box and those blades had the same issue.

Manufacturer Narrative

The blades specification has been updated to increase the surface area contact between the blade and blade holder.

• Brand Name: CALIBRATED LASIX BLADE (CLB) ML7070
• Type of Device: MICROKERATOME BLADE
• Manufacturer (Section D): MED-LOGICS, INC.; athens TX
• Manufacturer Contact: trey thorsen ; 1627 enterprise st; athens, TX 75751 ; 9495823891
• MDR Report Key: 4862286
• MDR Text Key: 15357450
• Report Number: 2085081-2015-00001
• Device Sequence Number: 1
• Product Code: HNO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ML7070
• Device Catalogue Number: ML7070CLB
• Device Lot Number: 1570081
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/21/2015
• Date Device Manufactured: 03/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1