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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. ANSPACH® EMAX2 PLUS MOTOR STEREOTAXIC DEVICE, ROBOTICS

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MAKO SURGICAL CORP. ANSPACH® EMAX2 PLUS MOTOR STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Catalog Number EMAX2PLUS
Device Problem Temperature Problem (3022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/11/2019
Event Type  Malfunction  
Manufacturer Narrative

As part of the normal complaint follow-up, an evaluation of the event has been initiated by mako surgical. A supplemental report will be submitted when additional information becomes available.

 
Event Description

The anspach overheated repeatedly during the procedure, and we continually reset the cutter to try and allow it to cool down. Eventually we could not proceed with the anspach and had to change it out for a different one to complete the case. Case type: pka. Surgical delay: 16-30 minutes.

 
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Brand NameANSPACH® EMAX2 PLUS MOTOR
Type of DeviceSTEREOTAXIC DEVICE, ROBOTICS
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
Manufacturer (Section G)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
Manufacturer Contact
bethany hinson
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key8288986
MDR Text Key134523691
Report Number3005985723-2019-00082
Device Sequence Number1
Product Code OLO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK080802
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/07/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/30/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberEMAX2PLUS
Device LOT NumberL22312427515
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/11/2019
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 01/30/2019 Patient Sequence Number: 1
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