MAUDE Adverse Event Report: MAKO SURGICAL CORP. LED, PUSHBUTTON AMBER BAYONET; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 200521

Device Problem Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/22/2019

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

Case number: (b)(4), mps (b)(6) requested service visit on robot.Case type: pka.Surgical delay: <30 min.

Event Description

Case number: (b)(4), mps (b)(6) requested service visit on robot.Case type: pka.Surgical delay: <30 min.

Manufacturer Narrative

Reported event: mps (b)(6) requested service visit on robot.Device evaluation and results: per (b)(4): mps (b)(6) requested i check the system for any issues.She indicated that brake release button led bulb wasn't turning on.Upon arrival, checked the brake release bulb and it was on.Replaced the amber bayonet led bulb part #200521 as a precaution.Checked system and found nothing wrong as it was operating normally with no issues.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 11/18/2010 1 device was inspected and 1 device was placed on: npr 10-10-0025, npr 10-10-0052, npr 10-10-0072, npr 10-10-0090, npr 10-10-0115, npr 10-11-0085, npr 10-11-0054, npr 10-11-0051, npr 10-10-0019, npr 10-10-0001, npr 10-10-0037, npr 10-10-0114, npr 10-06-0159, npr 10-06-0164, npr 10-08-0008, npr 10-10-0067, npr 10-10-0009, npr 10-10-0050, npr 10-11-0065, npr 10-11-0060 npr 10-11-0073.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 200521 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.

• Brand Name: LED, PUSHBUTTON AMBER BAYONET
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8871215
• MDR Text Key: 155629525
• Report Number: 3005985723-2019-00568
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 200521
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR