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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. RIO® DRAPE KIT-ONE PIECE WITH POCKETS- STEREOTAXIC DEVICE, ROBOTICS

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MAKO SURGICAL CORP. RIO® DRAPE KIT-ONE PIECE WITH POCKETS- STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Catalog Number 111320
Device Problems Material Split, Cut or Torn (4008); Non Reproducible Results (4029)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/12/2019
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
(b)(4), mako product specialist reported the following event: "the sterile protective sheet of the mako robot had a hole in its opening, not its packaging. A second sheet had to be opened to start the surgery. What measures/actions have been taken to complete the intervention? a second sheet was opened. " patient in the operating room at the time of discovery. Patient under anaesthesia.
 
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Brand NameRIO® DRAPE KIT-ONE PIECE WITH POCKETS-
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 Key8573056
MDR Text Key145302741
Report Number3005985723-2019-00330
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K050322
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 11/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number111320
Device Lot NumberD182631
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/10/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/02/2019 Patient Sequence Number: 1
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