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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 Problems Temperature Problem (3022); Non Reproducible Results (4029)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/17/2018
Event Type  Malfunction  
Manufacturer Narrative

¿as part of 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

Anspach tempurature increases significantly while burring and was making an abnormal high pitch sound (i presume it was just dying). The burr also has black residue left on it. Surgical delay -16-30 minutes. Case type: pka.

 
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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 Key8209245
MDR Text Key131918769
Report Number3005985723-2019-00003
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 02/15/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/02/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberEMAX2PLUS
Device LOT NumberK35311674611
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 Received01/21/2019
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: 01/02/2019 Patient Sequence Number: 1
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