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

Model Number SEEG DRILL ADAPTOR 3.20MM

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2021

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.Unique identifier (udi) #: (b)(4).

Event Description

The clinical representative (cr) was present for an ablation case.The 3.2 instrument adaptor was not going in to the instrument holder easily ¿ at first it didn¿t seem to fit, then it was very snug, so they switched to the site¿s other 3.2.At the end of the case, they tried to fit the original 3.2 into the instrument holder, and it eventually fit after trying a few times, but was very snug.

Manufacturer Narrative

The device was conform upon leaving the manufacturing site.This part was not returned because it is still used and is working properly.Some pictures were received for investigation, however the analysis of these pictures did not allow to determine the technical root cause of the event.

Event Description

The clinical representative (cr) was present for an ablation case.The 3.2 instrument adaptor was not going in to the instrument holder easily ¿ at first it didn't seem to fit, then it was very snug, so they switched to the site¿s other 3.2.At the end of the case, they tried to fit the original 3.2 into the instrument holder, and it eventually fit after trying a few times, but was very snug.

• 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: 11542244
• MDR Text Key: 242165956
• Report Number: 3009185973-2021-00077
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K200511
• 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: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SEEG DRILL ADAPTOR 3.20MM
• Device Catalogue Number: ROSAS00084
• Device Lot Number: MT-02-161 S160102
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1