MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF01, 5X150 KII FIOS ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTF01
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2021
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: laparoscopic left salpingo-oophorectomy.Event description: rep was not present in the case.Per the surgical services lead a trocar broke in a patient.Per the staff in the case, it is believed to be the surgeon's technique and the "insertion of the scope through the trocar was not gentle as it should have been." the trocar had been placed in the abdomen.Camera was being introduced into the trocar.Per the tech: dr was not as gentle as she had noted from other surgeons as he introduced camera down trocar.The trocar hinged on one side, still connected on one side.During manipulation of the trocar ¿ the entire piece separated.Per surgeons op note: i attempted to visualize the hepatic contour, but the plastic sleeve broke, in the mid location of the sleeve.The distal end was easily visualized, but i was not able to grasp it with the instruments, in order to remove it.The skin side was removed and the umbilical incision was extended and the tissue was cut until at the level of the break.The sleeve was grasped with the kelly clamp and it was gently pulled and removed.The two pieces seemed to form the previously intact sleeve.Larger trocar was a ctf33 according to the charges for the case.The ctf33 was also being used in the procedure, it is not the complaint device.Delay: maybe 5 minutes as the surgeons tried to discuss how to retrieve.Product available for return.Additional information was received via email and telephone on 02nov2021 from applied medical representative: confirmed that there was no patient injury.It is unknown how the trocar was inserted or if there was any difficulty during insertion.The break was jagged but did not cause particulation.Additional information was received via email on 04nov2021 from applied medical representative: a [ ] laparoscope was inserted in the trocar at the time of the event.Additional information was received via email on 12nov2021 from applied medical representative: there was no patient injury or illness associated with the complaint event.Type of intervention: the piece of trocar was removed from the patient.Patient status: there was no patient injury or illness associated with the complaint event.
Event or Problem Description
Procedure performed: laparoscopic left salpingo-oophorectomy event description: rep was not present in the case.Per the surgical services lead a trocar broke in a patient.Per the staff in the case, it is believed to be the surgeon's technique and the "insertion of the scope through the trocar was not gentle as it should have been." the trocar had been placed in the abdomen.Camera was being introduced into the trocar.Per the tech: dr was not as gentle as she had noted from other surgeons as he introduced camera down trocar.The trocar hinged on one side, still connected on one side.During manipulation of the trocar ¿ the entire piece separated.Per surgeons op note: i attempted to visualize the hepatic contour, but the plastic sleeve broke, in the mid location of the sleeve.The distal end was easily visualized, but i was not able to grasp it with the instruments, in order to remove it.The skin side was removed and the umbilical incision was extended and the tissue was cut until at the level of the break.The sleeve was grasped with the kelly clamp and it was gently pulled and removed.The two pieces seemed to form the previously intact sleeve.Larger trocar was a ctf33 according to the charges for the case.The ctf33 was also being used in the procedure, it is not the complaint device.Delay: maybe 5 minutes as the surgeons tried to discuss how to retrieve.Product available for return.Additional information was received via email and telephone on (b)(6) 2021 from applied medical representative: confirmed that there was no patient injury.It is unknown how the trocar was inserted or if there was any difficulty during insertion.The break was jagged but did not cause particulation.Additional information was received via email on (b)(6) 2021 from applied medical representative: a laparoscope was inserted in the trocar at the time of the event.Additional information was received via email on 12nov2021 from applied medical representative: there was no patient injury or illness associated with the complaint event.Type of intervention: the piece of trocar was removed from the patient.Patient status: there was no patient injury or illness associated with the complaint event.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a fractured cannula.The wall thickness of the cannula was measured and found to be within specifications.Based on the condition of the returned unit and the description of the event, it is likely that the cannula fractured due to a large force exerted on the unit during use.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• Brand Name: CTF01, 5X150 KII FIOS ZTHR 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: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 12821811
• Report Number: 2027111-2021-00718
• Device Sequence Number: 5760855
• Product Code: GCJ
• UDI-Device Identifier: 00607915124014
• UDI-Public: (01)00607915124014(17)240725(30)01(10)1421018
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K041795
• 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): 01/25/2022

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: 07/25/2024
• Device Model Number: CTF01
• Device Catalogue Number: 101412701
• Device Lot Number: 1421018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• 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: 10/29/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2021
• 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: KELLY CLAMP, CTF33, 5MM 0 DEGREE STRYKER SCOPE.
• Patient Sex: Unknown