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

Model Number ROSA 2.5.8

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Memory Loss/Impairment (1958); Paresis (1998); Coma (2417)

Event Date 07/10/2017

Event Type  Injury  

Manufacturer Narrative

The device (b)(4) has been inspected for investigation purpose. Based on the available information the incident was identified to be due to the following probable root causes: incorrect checking of the registration result by the operating surgeon, undetected patient head motion during the surgery, two electrodes may have passed through a vessel due to robot arm inaccurate position during the case, this inaccuracy most probably being due to the undetected patient head motion. Corrected data: date of this report; date received by manufacturer; evaluation code.

Manufacturer Narrative

As per additional information received from the hospital the patient is doing it a bit better and can speak normally without problem. The nasogastric probe has been removed and patient can eat also without problems. Patient still has some amnesia and some right hemiparesia but overall can stand up and walk without help.

Manufacturer Narrative

The operating surgeon indicated that there were no apparent issues noted intra-operatively and that the rosa device ro12020 had not malfunctioned during the subject surgery. The device has not been evaluated yet for investigation purpose. A medtech representative will go on customer site to inspect the device and determine the root cause of event. Once the evaluation will be performed, a follow-up medwatch report will be submitted.

Event Description

The surgeon reported that the patient underwent a seeg procedure to implant electrodes. The procedure was completed and the patient was transferred to the recovery room. It was stated that whilst in the recovery room that the patient suffered an acute subdural hematoma, lost consciousness and was transferred to the operating room for subdural haematoma evacuation. Additional information provided later by the operating surgeon indicates that there were no apparent issues noted intra-operatively and that the rosa device had not malfunctioned.

• Brand Name: ROSA SURGICAL DEVICE
• 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
• Manufacturer (Section G): MEDTECH SA; zac eureka; 900 rue du mas de verchant; montpellier, languedoc-roussillon 34000 ; FR 34000
• Manufacturer Contact: jay sharma ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 6803336
• MDR Text Key: 117872959
• Report Number: 3009185973-2017-00702
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: PK101791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: ROSA 2.5.8
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A

Patient Treatment Data

Date Received: 08/18/2017 Patient Sequence Number: 1