MAUDE Adverse Event Report: MAKO SURGICAL CORP. ANSPACH EMAX 2 PLUS BURR MOTOR; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 110940

Device Problems Power Problem (3010); Non Reproducible Results (4029)

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

Event Date 12/11/2018

Event Type  malfunction  

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

Anspach had no power.Case type: pka.Surgical delay: 16-30 minutes.

Manufacturer Narrative

Reported event: anspach emax 2 plus burr motor had no power.Method & results: -device evaluation and results: no device inspection could be completed as the product was not available for evaluation.Complaint history review: based on the device identification, the catsweb and trackwise complaint databases were reviewed from 2011 to present for similar reported events regarding anspach emax 2 plus burr motor had no power failure of p/n: 110940, s/n: (b)(4).There have been no other similar events for the referenced serial number.Conclusions: the failure mode could not be confirmed because the part was not available for evaluation.If device and/or additional information become available, this investigation will be reopened.Corrective action/preventive action: as the event did not involve a manufacturing related product problem indicating a non-conformity, adverse trend, or unanticipated hazard, no corrective action is required at this time.H3 other text : product was not available for evaluation.

Event Description

Anspach had no power.Case type: pka.Surgical delay: 16-30 minutes.

• Brand Name: ANSPACH EMAX 2 PLUS BURR MOTOR
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8196913
• MDR Text Key: 131490079
• Report Number: 3005985723-2018-00779
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K080802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 110940
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization