MAUDE Adverse Event Report: TRIMEDYNE, INC. 20444 VAPORMAX HOLMIUM SIDE FIRING FIBER; LASER FIBER

Model Number	20444
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Material Discolored (1170); Melted (1385); Overheating of Device (1437); Material Separation (1562); Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Fiber broke at the connector within half a minute after being opened.This information is documented as reported to trimedyne, inc.

• Brand Name: 20444 VAPORMAX HOLMIUM SIDE FIRING FIBER
• Common Device Name: LASER FIBER
• Manufacturer (Section D): TRIMEDYNE, INC.; 5 holland, building 223; irvine CA 92618 2579
• MDR Report Key: 8384306
• Report Number: 1419951-2019-00001
• Device Sequence Number: 1922931
• Product Code: GEX
• UDI-Device Identifier: M473204440
• UDI-Public: M473204440
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K053457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 09/30/2017
• Device Model Number: 20444
• Device Catalogue Number: 20444
• Device Lot Number: R10D034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 03/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1