MAUDE Adverse Event Report: MEDTECH SA ROSA BRAIN; COMPUTER-ASSISTED SURGICAL DEVICE

Model Number ROSAS00325

Device Problem Component Missing (2306)

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

Event Date 12/19/2018

Event Type  malfunction  

Manufacturer Narrative

The device has not been evaluated yet for investigation purpose.Once the evaluation is performed, a follow-up medwatch report will be submitted.  (b)(4).

Event Description

As the surgeon was attaching the patient to the robot, he noticed that the ratcheting handle on the side of the mayfield adaptor was loose.He was still able to attach the patient's head to the robot and continue the surgery as planned.The field service engineer was informed that morning, and went to the hospital to investigate that afternoon.It was found that the screw inside of the handle was missing.

Event Description

As the surgeon was attaching the patient to the robot, he noticed that the ratcheting handle on the side of the mayfield adaptor was loose.He was still able to attach the patient's head to the robot and continue the surgery as planned.The field service engineer was informed that morning, and went to the hospital to investigate that afternoon.It was found that the screw inside of the handle was missing.

Manufacturer Narrative

The mayfield head holder adaptor mt-02-268 s17004 was received at manufacturing site on (b)(6) 2019.

Manufacturer Narrative

It was reported that the handle of the mayfield adaptor was loose.A visual inspection of the mayfield adaptor was performed.It confirmed that the handle and the screw are loose due to the lack of the circlip to secure the attachment of the handle.The reason why the circlip is missing cannot be determined but it is likely due to the use of the mayfield adaptor.In addition the handle on the side of the adaptor is not missing as descitbed in the complaint description, however as per event description, the root cause is that the screw inside is missing.

Event Description

As the surgeon was attaching the patient to the robot, he noticed that the ratcheting handle on the side of the mayfield adaptor was loose.He was still able to attach the patient's head to the robot and continue the surgery as planned.The field service engineer was informed that morning, and went to the hospital to investigate that afternoon.It was found that the screw inside of the handle was missing.

• Brand Name: ROSA BRAIN
• Type of Device: COMPUTER-ASSISTED SURGICAL DEVICE
• Manufacturer (Section D): MEDTECH SA; zac eureka; 900 rue du mas de verchant; montpellier, languedoc-roussillon 34000 ; FR 34000
• MDR Report Key: 8256655
• MDR Text Key: 133344830
• Report Number: 3009185973-2019-00002
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K172444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROSAS00325
• Device Catalogue Number: MAYFIELD HEAD HOLDER ADAPTOR
• Device Lot Number: ROSA3-177E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1