MAUDE Adverse Event Report: MAKO SURGICAL CORP. HANDPIECE MICS; STEREOTAXIC DEVICE, ROBOTICS

Model Number 209063

Device Problems Device Difficult to Setup or Prepare (1487); Connection Problem (2900)

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

Event Date 10/16/2019

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

Mics prevented verification page from displaying ¿sweep up¿ screen during rio registration.Issue was resolved when new mics was attached.Case type: tka.Surgical delay: 16-30 minutes.Patient was under anesthesia.

Event Description

Mics prevented verification page from displaying ¿sweep up¿ screen during rio registration.Issue was resolved when new mics was attached.Case type: tka.Surgical delay: 16-30 minutes.Patient was under anesthesia.

Manufacturer Narrative

Mics prevented verification page from displaying ¿sweep up¿ screen during rio registration.Issue was resolved when new mics was attached.Case type: tka.Surgical delay: 16-30 minutes.Patient was under anesthesia.Product inspection: the product was not evaluated as the product was unavailable for inspection capa 2127499 has been raised for the same.Device history review: device history records indicate (b)(4) were manufactured under lot k06lc and all were accepted into final stock on 02/02/2016.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209063, lot number 42011215 shows no additional complaints related to the failure in this investigation.Conclusion: the alleged failure mode could not be confirmed as the product was not available for inspection.No additional investigation or specific actions are required.

• Brand Name: HANDPIECE MICS
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9233151
• MDR Text Key: 170315137
• Report Number: 3005985723-2019-00759
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030193
• UDI-Public: 00848486030193
• Combination Product (y/n): N
• PMA/PMN Number: K142530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 209063
• Device Catalogue Number: 209063
• Device Lot Number: 42011215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 10/24/2019
• Supplement Dates Manufacturer Received: 01/29/2020
• Supplement Dates FDA Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization