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

Model Number ARTICULATED MECHANICAL ARM

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

At the beginning of the surgery the medical staff noticed that the articulated arm plastic knob snapped off in the mayfield head holder adapter.

Manufacturer Narrative

No further investigation was needed for this incident in which the device (b)(4) was involved.(b)(4) has been raised in our quality management system in relation to articulated arm design issues.

Manufacturer Narrative

It has been identified during internal review that the reported manufacturer awareness date and event date were not correct.The event date was initially recorded as (b)(6) 2017, however this date should have been (b)(6) 2017.The awareness date was initially recorded as (b)(6) 2017, however this date should have been (b)(6) 2017.This medwatch report has been submitted to provide the correct awareness date and event date.This correction does not impact the timeliness of the previous reports or the investigation conclusions.

Manufacturer Narrative

This complaint is being remediated under an issue evaluation: complaints item numbers remediation.The item number was updated, the concerned medical device was the articulated mechanical arm and not the rosa robot.

Event Description

At the beginning of the surgery the medical staff noticed that the articulated arm plastic knob snapped off in the mayfield head holder adapter.

• 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: 6735368
• MDR Text Key: 80768024
• Report Number: 3009185973-2017-00662
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK101791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARTICULATED MECHANICAL ARM
• Device Catalogue Number: ROSAS00037
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2014
• 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 Sequence Number: 1