MAUDE Adverse Event Report: S.I.T. - SORDINA IORT TECHNOLOGIES SPA S.I.T. - SORDINA IORT TECHNOLOGIES SPA; LIAC 12 MEV

Model Number LIAC 12 MEV

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 03/02/2017

Event Type  malfunction  

Event Description

The event occurred during an iort treatment on thursday (b)(6) 2017 with liac sn (b)(4), installed in (b)(6) medical center - (b)(6), pertains to an interrupted treatment.The prescribed dose was 23.3 gy @ r100.The delivered dose has been 6 gy @ r100.During a technical analysis on liac sn (b)(4), carried out on installation site by the engineers of sit-sordina iort technologies spa on (b)(6) 2017, it has been detected that some connections of the wiring installed in the operating rooms were loose.Therefore the liac sn (b)(4) worked correctly causing the interruption of the treatment.

• Brand Name: S.I.T. - SORDINA IORT TECHNOLOGIES SPA
• Type of Device: LIAC 12 MEV
• Manufacturer (Section D): S.I.T. - SORDINA IORT TECHNOLOGIES SPA; galleria del pozzo rosso, 13; vicenza, vicenza 36100 ; IT 36100
• Manufacturer (Section G): SIT - SORDINA IORT TECHNOLOGIES SPA; galleria del pozzo rosso, 13; vicenza, vicenza 36100 ; IT 36100
• Manufacturer Contact: giuseppe carella ; galleria del pozzo rosso, 13; vicenza, vicenza 36100 ; IT 36100 ; 9069206244
• MDR Report Key: 6416778
• MDR Text Key: 70563472
• Report Number: 3010625741-2017-00001
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Service Personnel
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physicist
• Device Model Number: LIAC 12 MEV
• Device Catalogue Number: 900050002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 61 YR