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

Model Number N/A

Device Problems Component Incompatible (1108); Misassembly by Users (3133)

Patient Problem No Code Available (3191)

Event Date 03/28/2018

Event Type  Injury  

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

While installing the loaner system the distance sensor failed the kineverif test multiple times.The pointer probe passed on the first try, so it was confirmed that the arm was correctly calibrated.Another distance senor was brought in from another site and it also failed multiple kineverif tests.After speaking to a number of people on the team, it was suggested that the problem was due to the fact that we had an old distance sensor attaching to a new force sensor interface.After the issue was resolved, the distance sensor passed the kenieverif test twice and passed the applicative test.In total this postponed the case 8 hours, but the patient was not brought into the room until all tests were passed.Once the robot was in the operating room the case went smoothly, registration was good, and the case proceeded without any other delays.In order to keep this from happening again, a new distance sensor has been ordered so that it fits the new force sensor interface without any adjustments.

Event Description

While installing the loaner system at carilion memorial hospital, the distance sensor failed the kineverif test multiple times and each time the lighting, pool ball placement, and tightening of the support arm were adjusted.The pointer probe passed on the first try, so it was confirmed that the arm was correctly calibrated.Another distance senor was brought in from another site and it also failed multiple kineverif tests.After speaking to a number of people on the team, it was suggested that the problem was due to the fact that we had an old distance sensor attaching to a new force sensor interface.In order to correct for the slight deviation, it was suggested that the distance sensor's position be adjusted slight before tightening the screws.After trying this, the distance sensor passed the kineverif test twice and passed the applicative test.In total this postponed the case 8 hours, but the patient was not brought into the room until all tests were passed.Once the robot was in the or the case went smoothly, registration was good, and the case proceeded without any other delays.In order to keep this from happening again, a new distance sensor has been ordered so that it fits the new force sensor interface without any adjustments.

Manufacturer Narrative

It was reported that distance sensor repeatedly failed kineverif tests.A dhr review and a complaint history review were performed and did not identify any contributory factors to the event.A full analysis of data confirmed that kineverif tests failed multiple times.The ifu provide adequate information regarding the correct mounting of instruments on the rosa device.Therefore the root cause can be considered as a use error.It is noted that when the fse finally adjusted the distance sensor properly, the case went successfully.Patient code(s) : 3191 no code available : the surgery was postponed by 8 hours.Corrected data: date of this report.Additional device information.Date received by manufacturer.If follow-up, what type.Device evaluated by manufacturer.Device manufacturer date.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: 7464441
• MDR Text Key: 106608381
• Report Number: 3009185973-2018-00132
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: PK101791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: DISTANCE SENSOR
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other