MAUDE Adverse Event Report: ZAP SURGICAL SYSTEMS INC. ZAP-X RADIOSURGERY SYSTEM; MEDICAL CHARGED-PARTICLE RADIATION THERAPY SYSTEM

Model Number 300150

Device Problem Application Program Problem: Parameter Calculation Error (1449)

Patient Problem Insufficient Information (4580)

Event Date 04/06/2022

Event Type  malfunction  

Event Description

During treatment, tracking algorithm had difficulties aligning patient.

• Brand Name: ZAP-X RADIOSURGERY SYSTEM
• Type of Device: MEDICAL CHARGED-PARTICLE RADIATION THERAPY SYSTEM
• Manufacturer (Section D): ZAP SURGICAL SYSTEMS INC.; 590 taylor way, suite a; san carlos CA 94070
• Manufacturer (Section G): ZAP SURGICAL SYSTEMS INC.; 590 taylor way, suite a; san carlos CA 94070
• Manufacturer Contact: christopher brown ; 590 taylor way, suite a; san carlos, CA 94070
• MDR Report Key: 14716282
• MDR Text Key: 300469981
• Report Number: 3012039133-2022-00001
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00860183001504
• UDI-Public: (01)00860183001504
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K211663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 300150
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2020
• 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