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

Model Number ROSA 2.5.8

Device Problem Difficult To Position (1467)

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

Event Date 12/07/2016

Event Type  malfunction  

Manufacturer Narrative

Device has not been made available yet.

Event Description

Tightening knob not functioning.

Manufacturer Narrative

The tightening knob from device ro15063 was not available and therefore it was not possible to do an investigation or inspection to confirm the reported issue or determine the root cause for the event on this occasion.Documentation review indicates that the rosa device was manufactured in 2015 and installed in (b)(6) 2016.No issues or non-conformities related to tightening knob the were noted during the manufacturing process.The subject component, the tightening knob was installed in (b)(6) 2016.The event date was (b)(6) 2016.The component had been in use for 11 month.The root cause cannot be established on this occasion.Should the subject device become available in the future the investigation will be re-opened.A replacement part was provided to the customer.

• 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: elise lagacherie ; zac eureka; 900 rue du mas de verchant; montpellier, languedoc roussillon 34000 ; FR 34000 ; 467107740
• MDR Report Key: 6169241
• MDR Text Key: 62378874
• Report Number: 3009185973-2016-00001
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROSA 2.5.8
• Device Catalogue Number: ROSAS00003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1