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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO® ROBOTIC ARM - MICS; STEREOTAXIC DEVICE, ROBOTICS

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MAKO SURGICAL CORP. 3.0 RIO® ROBOTIC ARM - MICS; STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Catalog Number 209999
Device Problems Computer Software Problem (1112); Failure to Calibrate (2440)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/13/2019
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) - unable to pass rio registration & j6 locking up.Case type: tka; case was completed manually.Surgical delay: approximately 30 min.Problem: initially mps (b)(4) reported that she could not get the mics (multiple mics) to pass rio registration although the system would pass pre-surgery without issue.While working with the system further she experienced index encoder errors and eventually the arm locked up.
 
Event Description
(b)(4) - reported by (b)(6)- unable to pass rio registration & j6 locking up.Case type: tka; case was completed manually.Surgical delay: approximately 30 min.Problem: initially mps (b)(6) reported that she could not get the mics (multiple mics) to pass rio registration although the system would pass pre-surgery without issue.While working with the system further she experienced index encoder errors and eventually the arm locked up.
 
Manufacturer Narrative
Reported event: unable to pass rio registration & j6 locking up.Device evaluation and results: per (b)(4): the arm locked repeatedly during troubleshooting.I tried swapping backside cpci cards and the problem persisted on j6.I cleaned the glass encoder and the problem persisted.I took special measures to clean not only the glass but the encoder as well and that seemed to alleviate the problem.I had difficulty in getting my micro-e tool to operate correctly so i could not check encoder position.I did tighten the screws on the encoder and encoder bracket as well as extensively clean the glass.I also adjusted tensioin on j6 per service manual.Eventually, everything seemed to work correctly.To ensure full and complete operation i did complete a full kinematic calibration as well as j2 bump stop re-calibration and adjustment also did homing constants and wrapped it all up with a full successful has test.Notified mps and hospital staff of my results.Product history review: a review of the dhr associated with (b)(4) found quality inspection procedures successfully passed.Complaint history review : a review of complaints in catsweb and trackwise related to p/n 209999, serial number (b)(4) shows no additional complaints related to the failure in this investigation.Conclusions: system ready for clinical use.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.
 
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Brand Name
3.0 RIO® ROBOTIC ARM - MICS
Type of Device
STEREOTAXIC DEVICE, ROBOTICS
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
MDR Report Key8413469
MDR Text Key138575394
Report Number3005985723-2019-00219
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 05/06/2019
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 Catalogue Number209999
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 02/13/2019
Initial Date FDA Received03/12/2019
Supplement Dates Manufacturer Received04/25/2019
Supplement Dates FDA Received05/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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