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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. 2.7 DEGREE ANGLED SAGITAL SAW STEREOTAXIC DEVICE, ROBOTICS

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MAKO SURGICAL CORP. 2.7 DEGREE ANGLED SAGITAL SAW STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Model Number 212480
Device Problem Contamination of Device Ingredient or Reagent (2901)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/25/2019
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
This pi is for case 1 of 3: all case day the scrub nurse reported a grey greasy substance rubbing off onto gloves from the attachment pieces. We have three complete sets and all sets had to be re-run and flashed all day and still came up with the grey grease. The scrub nurse did not want to accept this onto the back table as no one could definitively state whether or not it was sterile. The or manager is wondering a couple things. One, is this happening at other accounts? if so, how are they navigating this? two, is there anything in writing that states that when this does occur, it is sterile and okay to proceed with the case? according the manager, if there was something in writing the scrub nurse and techs wouldn¿t be able to refuse taking the attachments at their own discretion. Looking for some direction for the management and sterilization department. Case type: tka. Update 12/november/2019 wg: as reported by rep: "this has probably happened in all three tka cases that day. The patients were in the room but not quite completely under. Not sure how you would consider that in terms of being ¿under anesthesia¿ as they only really do spinals at this hospital. The solution hasn¿t been resolved. They are waiting for official word, but as for now if they continue to come up with the grease or gray stuff they are deeming them unsterile and rejecting them. The procedure was completed successfully. I do not need replacements unless you deem it necessary. ".
 
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Brand Name2.7 DEGREE ANGLED SAGITAL SAW
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
alessandra chavez
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key9359837
MDR Text Key190637371
Report Number3005985723-2019-00824
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143752
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number212480
Device Catalogue Number212480
Device Lot Number3500469 / 35021216
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 11/21/2019 Patient Sequence Number: 1
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