MAUDE Adverse Event Report: CLARUS MEDICAL, LLC LASE ENDOSCOPIC DISCECTOMY SET

Model Number 1100-002

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/03/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023, clarus received communication from (b)(6) center about an issue with a lase device.During use, 'the tip broke off inside the patient disc leaving 3-5 mm of material'.

Manufacturer Narrative

The device was not returned to clarus for examination.The dhr showed no abnormalities during manufacturing and the device passed final inspection.After reviewing the rma database, email / verbal communication with customer, pictures provided by customer and internal review of the lase design, it can be concluded that the device more than likely had inadequate irrigation while in use causing the device to overheat.Additional information: incident was originally reported using form 5400 on 10 jan 2023.See attached form and fda response.See mw5114307.

• Brand Name: LASE ENDOSCOPIC DISCECTOMY SET
• Type of Device: LASE ENDOSCOPIC DISCECTOMY SET
• Manufacturer (Section D): CLARUS MEDICAL, LLC; 13355 10th ave n; ste 110; plymouth MN 55441
• Manufacturer (Section G): CLARUS MEDICAL, LLC; 13355 10trh ave n; ste 110; plymouth MN 55441
• Manufacturer Contact: mark brown ; 13355 10th ave n; ste 110; plymouth, MN 55441 ; 7635258445
• MDR Report Key: 16659708
• MDR Text Key: 312490280
• Report Number: 2183911-2023-00001
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040424
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1100-002
• Device Catalogue Number: 1100-002
• Device Lot Number: 57413
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2022
• 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
• Patient Outcome(s): Other