MAUDE Adverse Event Report: TRIMEDYNE, INC. 20471-HP OMNI MULTIUSE HANDPIECE WITH FIBER ASSY; LASER FIBER

Model Number	20471-HP
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Material Discolored (1170); Melted (1385); Overheating of Device (1437); Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This event was initially determined to not be reportable based on the initial report.However, additional information provided by the customer on 06/15/2018 led to the decision to report.(b)(4).
Event or Problem Description
Customer stated that the 20471-hp was fused and shrunk in the middle of the handpiece when it was used together with 20371-hp.It only had a little energy output after lasing less than 1 minute.Our qc found it is still passing light.Customer stated at a later date "after the fiber assembly was connected to the equipment, the doctor stepped on the pedals for less than 1 minute.He stopped using the camera when the handle had been melted and the doctor's hand was burnt.There are no problems with checking the handles and equipment." this information is documented as reported to trimedyne, inc.
Additional Manufacturer Narrative
Note: the manufacturer completed all of the information on this form.(b)(4).

• Brand Name: 20471-HP OMNI MULTIUSE HANDPIECE WITH FIBER ASSY
• Common Device Name: LASER FIBER
• Manufacturer (Section D): TRIMEDYNE, INC.; 5 holland, building 223; irvine CA 92618 2579
• MDR Report Key: 7705168
• Report Number: 1419951-2018-00002
• Device Sequence Number: 2770969
• Product Code: GEX
• UDI-Device Identifier: M47320471HP0
• UDI-Public: M47320471HP0
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K962632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Expiration Date: 03/31/2021
• Device Model Number: 20471-HP
• Device Catalogue Number: 20471-HP
• Device Lot Number: 17C012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/04/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 55