MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (OBERKOCHEN) INTRABEAM IORT; SYSTEM, THERAPEUTIC, X-RAY

Model Number XRS-4

Device Problems Failure to Deliver Energy (1211); Output Problem (3005)

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

Event Date 07/17/2019

Event Type  malfunction  

Event Description

Pt was planned to undergo right partial mastectomy with intraoperative radiation therapy (iort).Earlier, the quality assurance procedure on the iort machine was completed with no issues.The surgeon placed the 3.5 cm applicator into the lumpectomy cavity.We then stepped to the console area to review the treatment.All of the treatment parameters were loaded into the console.Again, no errors were noted.The "start" button was pressed.However, the console returned with an error.Treatment could not be initiated.The radiation oncologist, medical physicist, surgeon and vendor rep were present during these events.Immediately after the case we went through an extensive troubleshooting process with the vendor and medical physicist.Since we have had an incident prior ((b)(6) 2019), a new machine head had already been obtained.The new machine head was used in the event today.We went to an adjacent operating room.We then repeated the qa process and no issue were encountered.We then placed the 5 cm applicator inside a saline bath to simulate treatment.We manipulated the wires extensively with the hypothesis this may be a contributing factor.The treatment was able to be initiated and delivered without any issues.The next variable was whether the 3.5 cm applicator was causing the error.We requested this applicator back from sterile processing.We repeated the qa and then placed the 3.5 cm applicator on the machine.The applicator was placed in the water bath.Treatment was again initiated and could be delivered without incident.We paused the treatment, stepped in the room and placed saline bags against the applicator to simulate pressure from the body.Again, treatment could be delivered and no error or incident was noted.During this time, the vendor contacted support in (b)(4).The error code that was received appeared to correlate with an issue with the cabling and wires.However, we were unable to reproduce the error in a simulated environment despite multiple attempts.The radiation oncologist and the surgeon (referring provided) spoke immediately with the family and spoke with the pt after she recovered.No harm reached the pt as radiation was not delivered.In f/u and after review of final pathology, we will discuss treatment options which may include external beam radiation therapy or no radiation therapy.Fda safety report id# (b)(4).

• Brand Name: INTRABEAM IORT
• Type of Device: SYSTEM, THERAPEUTIC, X-RAY
• Manufacturer (Section D): CARL ZEISS MEDITEC AG (OBERKOCHEN); oberkochen 73446 ; GM 73446
• MDR Report Key: 8817044
• MDR Text Key: 152042615
• Report Number: MW5088283
• Device Sequence Number: 1
• Product Code: JAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: XRS-4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR