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

Catalog Number 209999

Device Problem Device Reprocessing Problem (1091)

Patient Problem Tissue Damage (2104)

Event Date 10/20/2016

Event Type  Injury  

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

While the rep was cleaning the knee end effector that holds the burr, the rep cut herself.The robot number is (b)(4).

Manufacturer Narrative

Reported event: the event reported that a user was cut through their glove during cleaning of the robotic arm post-procedure.The user was cut by a partial knee end effector.No device failure occurred.Device history review: a review of the dhr associated with rio 095 found quality inspection procedures successfully passed.Device evaluation and results: no failure occurred with the device.The user was cleaning the device and the body of the knee end effector pierced through the user's glove and cut them.Complaint history review: review of complaints within the (b)(6) database for rob 095 show no other complaint related to the reported event in this investigation.Conclusion: no failure occurred with the device.Monitoring of complaints for this incident type or similar will take place.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.

Event Description

While the rep was cleaning the knee end effector that holds the burr, the rep cut herself.The robot number is rob095.

• Brand Name: 3.0 RIO® ROBOTIC ARM - MICS
• Type of Device: STEREOTACTIC 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: liza gordillo ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 6074203
• MDR Text Key: 59008882
• Report Number: 3005985723-2016-00358
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112507
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other