MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFR73, 12X100 KII OPT ADVFIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFR73
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to be returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: nephrectomy by [name] robot.Event description: after the instrument was properly set up and inserted into the abdominal cavity, the endoscope was inserted.However, it was discovered that the tip of the trocar had fractured, causing fragments to fall inside the patient's body.The medical personnel have already successfully removed the fragments from the patient's body.There is no impact to patient.User replace with a new one to complete this surgery.There is no other instruments to effect this event.Product is available for return.Additional information received on 17may2023 via email from the distributor the trocar was rotated in alternating clockwise and counterclockwise directions.There was no difficulty during insertion.The robot model is xi, which does not utilize clamps.It first sets cfr73 and then proceeds to enter the trocar using the camera from [robot].Endoscope was inside the cannula at the time of the incident.Type of intervention: user replace with a new one to complete this surgery.Patient status: fine.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a clear fragment.Visual inspection confirmed the complainant¿s experience of a cannula tip fracture.The clear fragment was identified to be part of the cannula tip.Based on the condition of the returned unit, it is likely that the fractured cannula tip was caused by an object or instrument coming into contact with the cannula tip and/or excess force was exerted on the tip during the procedure.It is also possible that the cannula tip material was more susceptible to fracture.
Event or Problem Description
Procedure performed: nephrectomy by [name] robot.Event description: after the instrument was properly set up and inserted into the abdominal cavity, the endoscope was inserted.However, it was discovered that the tip of the trocar had fractured, causing fragments to fall inside the patient's body.The medical personnel have already successfully removed the fragments from the patient's body.There is no impact to patient.User replace with a new one to complete this surgery.There is no other instruments to effect this event.Product is available for return.Additional information received on 17may2023 via email from the distributor the trocar was rotated in alternating clockwise and counterclockwise directions.There was no difficulty during insertion.The robot model is xi, which does not utilize clamps.It first sets cfr73 and then proceeds to enter the trocar using the camera from [robot].Endoscope was inside the cannula at the time of the incident.Type of intervention: user replace with a new one to complete this surgery.Patient status: fine.

• Brand Name: CFR73, 12X100 KII OPT ADVFIX 6/BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 16964240
• Report Number: 2027111-2023-00465
• Device Sequence Number: 12135354
• Product Code: GCJ
• UDI-Device Identifier: 00607915119898
• UDI-Public: (01)00607915119898(17)251030(30)01(10)1471611
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K083638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2023

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: 10/30/2025
• Device Model Number: CFR73
• Device Catalogue Number: 101245601
• Device Lot Number: 1471611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2023
• Supplement Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI XI, ENDOSCOPE
• Patient Sex: Unknown