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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. HANDPIECE MICS; STEREOTAXIC DEVICE, ROBOTICS
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MAKO SURGICAL CORP. HANDPIECE MICS; STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Model Number 209063
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/07/2019
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
Handle keeps falling off.Case type: tka.Update: mps response "the screw in the bottom of the device was loose, so it fell off with the grey handle.But it was found and cleaned for return with the mics.".
 
Event Description
Handle keeps falling off.Case type: tka.Update: mps response "the screw in the bottom of the device was loose, so it fell off with the grey handle.But it was found and cleaned for return with the mics".
 
Manufacturer Narrative
Handle keeps falling off.Case type: tka.Update: mps response "the screw in the bottom of the device was loose, so it fell off with the grey handle.But it was found and cleaned for return with the mics".Product inspection.As per service maxwo-02199654 & case number (b)(4).Mics-209063 sn#(b)(6) lot#42060519 rma#284279 senior depot service technician: (b)(6).1.Successfully performed mics cable replacement per d06917.Mics can be returned to stock as a 209063 sn#(b)(6).The alleged failure was not confirmed.Device history review.Device history records indicate (b)(4) devices were manufactured under lot k0cwf and (b)(4) devices were accepted into final stock on 05-29-2019.Complaint history review.A review of complaints in catsweb and trackwise related to p/n 209063, lot number 42060519 shows no additional complaints related to the failure in this investigation.Conclusion.The device failure mode identified during inspection is not consistent with the reported issue.No additional investigation or specific actions are required.
 
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Brand Name
HANDPIECE MICS
Type of Device
STEREOTAXIC DEVICE, ROBOTICS
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
MDR Report Key9396774
MDR Text Key177391155
Report Number3005985723-2019-00872
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00848486030193
UDI-Public00848486030193
Combination Product (y/n)N
PMA/PMN Number
K142530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 03/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number209063
Device Catalogue Number209063
Device Lot Number42060519 / 4206692
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2019
Date Manufacturer Received02/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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