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

Model Number OPTICAL DISTANCE SENSOR

Device Problem Calibration Problem (2890)

Patient Problem No Patient Involvement (2645)

Event Date 08/02/2019

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.

Event Description

During the applicative test for the preventive maintenance, the field service engineer did the laser registration.The result on validation looked ok, but not perfect.During the first run, not all bullets were hit.Second run on laser registration, was better, but still not all bullets were "hitten".The fse changed to marker registration, since the ct was brand new from (b)(6) 2019 from (b)(6).With the marker registration the validation was perfect and all bullets were "hitten".

Event Description

During the applicative test for the preventive maintenance, the field service engineer did the laser registration.The result on validation looked ok, but not perfect.During the first run, not all bullets were hit.Second run on laser registration, was better, but still not all bullets were hitten.The fse changed to marker registration, since the ct was brand new from 01-08-2019 from frankfurt.With the marker registration the validation was perfect and all bullets were hitten.

Manufacturer Narrative

Conclusions : the code 4307 was chosen as the technical root cause of the event was determined to be the imagery of the phantom.It was reported that fse noticed that the applicative test did not passed when the registration was performed with the distance sensor while it passed with a markers registration.Device history record review and complaint history review were not performed based on the low severity of this complaint.According to technical investigation, the issue was due to the imagery that no longer represents the current state of the phantom head.Corrected data: date of this report, date received by manufacturer, if follow-up, what type, device evaluated by manufacturer, event problem and evaluation codes, remedial action.

• 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
• MDR Report Key: 8934393
• MDR Text Key: 203889116
• Report Number: 3009185973-2019-00292
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K101791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: OPTICAL DISTANCE SENSOR
• Device Catalogue Number: ROSAS00016
• Device Lot Number: ROSA-075K
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1