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

Model Number SEEG DRILL ADAPTOR 2.45MM

Device Problem Degraded (1153)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2020

Event Type  malfunction  

Manufacturer Narrative

The device was conform on leaving manufacturing site. This part was not returned for investigation, the technical root cause of the event could not be determined. However, this topic is addressed through a capa, and the conclusion of the investigations already performed, concluded that the drill adaptor design must be improved. Unique identifier (udi) #: unknown.

Event Description

The clinical representative (cr) was present for a seeg case. Once the surgeon was ready to begin drilling, he noticed that there was a strange catch in the 2. 45 drill adaptor, and that the bolt and driver would not pass through it easily. The surgeon swapped out the drill adaptor for a different one, and was able to continue the case without any problems. Delay to case about 5 mins, after patient was under anesthesia, and after first incision. No patient impact.

• 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
• Manufacturer (Section G): MEDTECH SA; zac eureka; 900 rue du mas de verchant; montpellier, languedoc-roussillon 34000 ; FR 34000
• Manufacturer Contact: jay sharma ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 10842649
• MDR Text Key: 218239054
• Report Number: 3009185973-2020-00304
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200511
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/26/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: SEEG DRILL ADAPTOR 2.45MM
• Device Catalogue Number: ROSAS00082
• Device Lot Number: ROSA3-283A
• Was Device Available for Evaluation?: Yes

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 10/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A