MAUDE Adverse Event Report: MAKO SURGICAL CORP. DOUBLE SHRINK HYBRID CABLE; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 206083-01

Device Problems Electrical /Electronic Property Problem (1198); Mechanical Problem (1384)

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

Event Date 07/03/2019

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

Case number: (b)(4), mps (b)(6) reported hybrid cable loose and difficulty getting fisso arm to tighten.Update: problem noticed loose cables were noticed intra-op prior to making cuts when there was a software error that came up.Case type: pka.Surgical delay: 20 minutes.Update: was the patient under anesthesia? as per mps: yes the patient was under anesthesia.Case cancelled: no.Case completed successfully: yes.Case completed manually: no, i was able to re-tighten cables as well as troubleshoot the software issue that the system was giving me.We were able to complete the case robotically.Investigation results: yes.

Manufacturer Narrative

Reported event: "case number: (b)(4), mps (b)(4) reported hybrid cable loose and difficulty getting fisso arm to tighten.Update: ""problem noticed- loose cables were noticed intra-op prior to making cuts when there was a software error that came up.Case type: pka.Surgical delay- 20 minutes.Update: was the patient under anesthesia? as per mps: ""yes the patient was under anesthesia."" case cancelled- no.Case completed successfully - yes.Case completed manually- no, i was able to re-tighten cables as well as troubleshoot the software issue that the system was giving me.We were able to complete the case robotically.Investigation results- yes.""" device evaluation and results: per 03744563: fse replaced part number 206083-01 double shrink hybrid cable.System was found to be within mako tolerances and specifications.Product history review: a review of device history records shows that on 04/06/10 1 device was inspected and no data device was placed on: (b)(4).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 206083-01 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.

Event Description

Case number: (b)(4), mps (b)(4) reported hybrid cable loose and difficulty getting fisso arm to tighten.Update: "problem noticed- loose cables were noticed intra-op prior to making cuts when there was a software error that came up.Case type: pka.Surgical delay- 20 minutes.Update: was the patient under anesthesia? as per mps: "yes the patient was under anesthesia".Case cancelled- no.Case completed successfully - yes.Case completed manually- no, i was able to re-tighten cables as well as troubleshoot the software issue that the system was giving me.We were able to complete the case robotically.Investigation results- yes.".

• Brand Name: DOUBLE SHRINK HYBRID CABLE
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8795644
• MDR Text Key: 155931370
• Report Number: 3005985723-2019-00516
• 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: 11/04/2019

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 Catalogue Number: 206083-01
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/03/2019
• Initial Date FDA Received: 07/16/2019
• Supplement Dates Manufacturer Received: 10/24/2019
• Supplement Dates FDA Received: 11/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization