MAUDE Adverse Event Report: MEDTECH SA CANNULA D6/2.5MM L200MM; COMPUTER-ASSISTED SURGICAL DEVICE

Model Number N/A

Device Problem Degraded (1153)

Patient Problem No Patient Involvement (2645)

Event Date 10/16/2020

Event Type  malfunction  

Manufacturer Narrative

Reportedly, scratches were noticed on the surface of the cannula.The device was conform when leaving the manufacturing site.This event was reported only after surgery, no information about its last utilisation is available.The part was not returned for analysis because of hospital policy restrictions.The technical root cause of the event could not be determined.Udi# : unknown.

Event Description

On (b)(6) 2020, after a rosa spine procedure, the user found the scratches on the surface of cannula.

• Brand Name: CANNULA D6/2.5MM L200MM
• 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: 10792526
• MDR Text Key: 214799480
• Report Number: 3009185973-2020-00293
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ROSAS00167
• Device Lot Number: ROSA3-157A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 11/05/2020
• 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
• Patient Sequence Number: 1