MAUDE Adverse Event Report: MONTERIS MEDICAL CORPORATION CONNECTOR MODULE

Model Number	20336-D
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/31/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the training of a new surgeon, the connector module (cm) melted at the connection to the test laser.It was noted that the monteris representative did not click in the laser fiber twice, and that after firing for a few minutes, it was realized what happened.The backup cm was swapped to complete the training.There were no patient complications reported in relation to this event.
Additional Manufacturer Narrative
Device evaluation: the connector module was visually examined and the failure mode was confirmed.This is an "old" design of the connector module, where this is a known failure mode due to the probe fiber not being fully inserted into the connector module causing laser energy to melt the e2k mating adapter.

• Brand Name: CONNECTOR MODULE
• Common Device Name: CONNECTOR MODULE
• Manufacturer (Section D): MONTERIS MEDICAL CORPORATION; 14755 27th ave n; suite c; plymouth MN 55447
• MDR Report Key: 6896448
• Report Number: 3009970070-2017-00150
• Device Sequence Number: 10987607
• Product Code: GEX
• UDI-Device Identifier: 00816589020403
• UDI-Public: 00816589020403
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K162762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 20336-D
• Device Catalogue Number: 025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/31/2017
• Supplement Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 09/26/2017
• Supplement Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1