MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0R50, 12X130 KII BALLOON BLNT TIP 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C0R50
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit has been returned to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: left inferior lobectomy procedure with robot.Event description: the operating room reported a c0r50 trocar that broke during a left inferior lobectomy procedure with robot.The end broke during the passage of the robot camera.A piece of plastic fell in the chest.It has been removed.Additional information received by email from applied medical representative on 1july19: it was not a part of the seal but a part of the distal tip of the cannula.It seems that it was torn off.Intervention: it has been removed.Patient status: ok.
Event or Problem Description
Procedure performed: left inferior lobectomy procedure with robot.Event description: the operating room reported a c0r50 trocar that broke during a left inferior lobectomy procedure with robot.The end broke during the passage of the robot camera.A piece of plastic fell in the chest.It has been removed.Original: le bloc opératoire nous a rapporté un trocart c0r50 qui a cassé lors d'une intervention de lobectomie inférieure gauche au robot.L'extrémité a cassé lors du passage de la caméra robot.Un morceau de plastique est tombé dans le thorax.Il a été retiré.Additional information received by email from applied medical representative on 1july19 it was not a part of the seal but a part of the distal tip of the cannula.It seems that it was torn off.Intervention: it has been removed.Patient status: ok.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a cannula tip fracture.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by an instrument or object that came into contact with the cannula tip during the procedure or manipulation of the robot during use.The returned unit is not validated for robotic use.

• Brand Name: C0R50, 12X130 KII BALLOON BLNT TIP 6/BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8791732
• Report Number: 2027111-2019-00516
• Device Sequence Number: 19317137
• Product Code: GCJ
• UDI-Device Identifier: 00607915116460
• UDI-Public: (01)00607915116460(17)211202(30)01(10)1342828
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K060629
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/02/2021
• Device Model Number: C0R50
• Device Catalogue Number: 101451901
• Device Lot Number: 1342828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/21/2019
• Supplement Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 07/15/2019
• Supplement Report FDA Received Date: 08/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROBOT CAMERA