MAUDE Adverse Event Report: MONTERIS MEDICAL CORPORATION FULLFIRE DIFFUSING TIP LASER PROBE; FULLFIRE¿ DIFFUSING TIP LASER PROBE

Catalog Number DTP-001-01

Device Problems Bent (1059); Charred (1086); Device Operates Differently Than Expected (2913)

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

Event Date 08/21/2017

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: the device was returned and had black artifact and damaged peek material at the distal end.

Event Description

It was reported that following an ablation procedure, after finishing the case, the user went to pull out the probe of the robotic probe driver (rpd) and bolt.It was noted that it was very difficult to pull out.Once the probe was out, it was noticed that it "didn't look right" and that the probe had a slight bend in it and that it was darker around the tip.There were no patient complications reported in relation to this event.If additional information is received, a follow up report will be submitted.

• Brand Name: FULLFIRE DIFFUSING TIP LASER PROBE
• Type of Device: FULLFIRE¿ DIFFUSING TIP LASER PROBE
• Manufacturer (Section D): MONTERIS MEDICAL CORPORATION; 14755 27th ave n; suite c; plymouth MN 55447
• Manufacturer (Section G): MONTERIS MEDICAL CORPORATION; 14755 27th ave n; suite c; plymouth MN 55447
• Manufacturer Contact: jordon honeck ; 14755 27th ave n; suite c; plymouth, MN 55447
• MDR Report Key: 6859596
• MDR Text Key: 86151702
• Report Number: 3009970070-2017-00132
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00816589020601
• UDI-Public: 00816589020601
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2019
• Device Catalogue Number: DTP-001-01
• Device Lot Number: C8092-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2017
• 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