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

Model Number INSTRUMENT HOLDER

Device Problem Fitting Problem (2183)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/19/2020

Event Type  Injury  

Manufacturer Narrative

Udi# : (b)(4).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 surgery, but prior to first incision, the instrument holder (mt-02-158 s18108) could not be placed onto the end of the robot arm by the surgeon.Upon further inspection, there appeared to be notches/grooves around the center inset circle that fits onto the robot arm.The instrument holder had to be filed down around this circle inset in order to get the instrument holder to sit flush onto the robot arm.It was determined that the robot arm had no issue as the pointer probe and laser attachments sat flush with no force needed.The process of getting the instrument holder attached to the robot arm delayed surgery by 30-45 minutes while the patient was under anesthesia.

Manufacturer Narrative

It was reported that during surgery, the instrument holder (b)(6) could not be placed onto the end of the robot arm by the surgeon.Upon further inspection, there appeared to be notches/grooves around the center inset circle that fits onto the robot arm.Photos provided permitted to confirm the event.The most probable root cause of the damage of the instrument holder is a shock caused by a fall of the instrument or by a shock with another instrument.This cannot be confirmed.Corrected data: b4: date of this report.G3: date received by manufacturer.H2: if follow-up, what type.H3: device evaluated by manufacturer.H6: adverse event problem.H10: additional narratives/data.H3 other text: device was not returned to manufacturer.

Event Description

During surgery, but prior to first incision, the instrument holder (b)(6) could not be placed onto the end of the robot arm by the surgeon.Upon further inspection, there appeared to be notches/grooves around the center inset circle that fits onto the robot arm.The instrument holder had to be filed down around this circle inset in order to get the instrument holder to sit flush onto the robot arm.It was determined that the robot arm had no issue as the pointer probe and laser attachments sat flush with no force needed.The process of getting the instrument holder attached to the robot arm delayed surgery by 30-45 minutes while the patient was under anesthesia.

• Brand Name: ROSA ONE
• 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: 10520363
• MDR Text Key: 206493116
• Report Number: 3009185973-2020-00207
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K182417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INSTRUMENT HOLDER
• Device Catalogue Number: ROSAS00358
• Device Lot Number: ROSA3-275A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other