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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 Output Problem (3005); Problem with Software Installation (3013)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/08/2019
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
Case number: (b)(4), mps (b)(6) reported mics not getting power once in haptics.Case type: tka.Surgery was not completed robotically.Update: "< 30 min surgical delay.Procedure completed manually, last 2 angled cuts were done manually".
 
Event Description
Case number: (b)(4), mps (b)(6) reported mics not getting power once in haptics.Case type: tka.Surgery was not completed robotically.Update: "< 30 min surgical delay.Procedure completed manually, last 2 angled cuts were done manually.
 
Manufacturer Narrative
Reported event: mps (b)(6) reported mics not getting power once in haptics.Device evaluation and results: per wo-(b)(4): successfully performed mics status check.Performed burr override and mics functioned.System investigation completed successfully as per service manual.All system checks and tests passed.Product history review: a review of device history records shows that on 02/17/15 1 device was inspected and 1 device was placed on: npr 15-01-0032.A review of the data revealed that the non-conformances are not related to the failure alleged in this compliant.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209999, serial number (b)(6) 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 Key8645336
MDR Text Key146247948
Report Number3005985723-2019-00389
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00848486030407
UDI-Public00848486030407
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 07/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2019
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
Date Manufacturer Received07/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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