• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO ROBOTIC ARM - MICS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAKO SURGICAL CORP. 3.0 RIO ROBOTIC ARM - MICS; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 209999
Device Problem Difficult or Delayed Positioning (1157)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/05/2020
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
(b)(4) - mps manager reported difficulty passing sawblade checkpoint and arm shaking when moving into haptics.Case type: not reported.
 
Manufacturer Narrative
Reported event: it was reported that "mps reported difficulty passing sawblade checkpoint and arm shaking when moving into haptics.Case type : not reported.¿ product evaluation and results: the field service engineer reported: problem reproduced? yes.Trouble shooting notes: none.Work performed: adjusted j2,j3,j5 for optimization.All tests passed on initial visit, adjustments to tighten and movement.Work order disposition: system investigation completed successfully as per service manual.All system checks and tests passed, system is ready for use.Product history review: a review of device history records shows that rob991 was inspected on 19/09/2019 and was handled via qt.A review of the data revealed that the non-conformances is not related to the failure alleged in this complaint.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 219999, rob# rob991 shows no additional complaints related to the failure in this investigation.Conclusions: (per preventive maintenance is where an action occurs that identifies device deterioration which may compromise function.Under pm conditions no patient was involved and no actual or potential patient harm existed for the alleged event.) the failure was confirmed.Adjusted j2,j3,j5 for optimization.All tests passed on initial visit, adjustments to tighten and movement.System is ready for clinical use.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
 
Event Description
Rob991 - mps manager reported difficulty passing sawblade checkpoint and arm shaking when moving into haptics.Case type : not reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
3.0 RIO ROBOTIC ARM - MICS
Type of Device
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
MDR Report Key9911558
MDR Text Key185990415
Report Number3005985723-2020-00189
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00848486030407
UDI-Public00848486030407
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 07/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number209999
Device Catalogue Number209999
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 03/05/2020
Initial Date FDA Received04/01/2020
Supplement Dates Manufacturer Received06/16/2020
Supplement Dates FDA Received07/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
-
-