MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF73, 12X100 KII FIOS ADVFIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFF73
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2023
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: robotic sigmoid colectomy, fistula takedown, ileostomy creation event description: the kii balloon blunt tip trocar was hit by a robotic arm within the abdomen causing the tip of the trocar to break off.No one was hurt.They opened up a new trocar and inserted it in to complete the case.No patient injury.Product is available for return.Additional information was received via email on 16oct2023 from applied medical, account manager associate: a kii balloon blunt tip trocar was used during a robotic case and mid-procedure the tip was broken by a swinging robotic arm.Another trocar was used to finish the case.The trocar was saved.Additional information was received via email on 18oct2023 from applied medical, account manager associate: cff73 lot #1490705 broke during robotic sigmoid colectomy, fistula takedown, ileostomy creation.Robotic instrument arms, (prograsp, small grasping retractor, vessel sealer) were being used at the time of the event.The intuitive surgical / size 8mm instrument clamp was used int the robotic surgery.The cannula tip broke inside the patient abdomen.The obturator was not inside the cannula at the time of the incident.The break was considered to be a clean break.The break did not cause particulation.All pieces were retrieved from the patient.The trocar was inserted by rotating in an alternating clockwise and counterclockwise direction.There was no difficulty during insertion.No instruments were inside the cannula at the time of the incident.Type of intervention: they opened up a new trocar and inserted it in to complete the case.Patient status: no patient injury.
Event or Problem Description
Procedure performed: robotic sigmoid colectomy, fistula takedown, ileostomy creation event description: the kii balloon blunt tip trocar was hit by a robotic arm within the abdomen causing the tip of the trocar to break off.No one was hurt.They opened up a new trocar and inserted it in to complete the case.No patient injury.Product is available for return.Additional information was received via email on 16oct2023 from applied medical, account manager associate: a kii balloon blunt tip trocar was used during a robotic case and mid-procedure the tip was broken by a swinging robotic arm.Another trocar was used to finish the case.The trocar was saved.Additional information was received via email on 18oct2023 from applied medical, account manager associate: cff73 lot #1490705 broke during robotic sigmoid colectomy, fistula takedown, ileostomy creation.Robotic instrument arms, (prograsp, small grasping retractor, vessel sealer) were being used at the time of the event.The intuitive surgical /size 8mm instrument clamp was used int the robotic surgery.The cannula tip broke inside the patient abdomen.The obturator was not inside the cannula at the time of the incident.The break was considered to be a clean break.The break did not cause particulation.All pieces were retrieved from the patient.The trocar was inserted by rotating in an alternating clockwise and counterclockwise direction.There was no difficulty during insertion.No instruments were inside the cannula at the time of the incident.Additional information was received via email on 20nov2023 from account manager associate, applied medical: there was no mention of a bag involvement initially so i am confident it was not involved.Rep will confirm when point of contact responds.Additional information was received via email on 21nov2023 from account manager associate, applied medical: my contact has informed that there was no issue with the bag.Type of intervention: they opened up a new trocar and inserted it in to complete the case.Patient status: no patient injury.
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 and the description of the event, it is likely that the fractured cannula tip was caused by a robotic arm coming into contact with the cannula tip causing it to crack and fragment.It is also possible that the cannula tip material was more susceptible to fracture.The event unit is not validated for robotic use.

• Brand Name: CFF73, 12X100 KII FIOS 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: 17997185
• Report Number: 2027111-2023-00664
• Device Sequence Number: 5884785
• Product Code: GCJ
• UDI-Device Identifier: 00607915117658
• UDI-Public: (01)00607915117658(17)260427(30)01(10)1490705
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2024

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: 04/27/2026
• Device Model Number: CFF73
• Device Catalogue Number: 101245501
• Device Lot Number: 1490705
• 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: 10/12/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2023
• 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
• Patient Sex: Unknown