MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF33, 11X100 KII FIOS ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTF33
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: robotic hiatal hernia event description: rep was not present for the case.After the trocar was placed in the abdomen and fully seated, a camera was placed down the trocar then they heard a pop and the trocar snapped in half.There was no patient injury.The case was completed with a new device.Product is available for return.Additional information received on 10aug2022 via phone call from user facility: incomplete, (7/8) break occurred in middle of cannula after placing instrument through cannula.The break did not fragment.The trocar was inserted normally with no difficulty during insertion.Type of intervention: the case was completed with a new applied trocar.Patient status: no patient injury.
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.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: robotic hiatal hernia.Event description: rep was not present for the case.After the trocar was placed in the abdomen and fully seated, a camera was placed down the trocar then they heard a pop and the trocar snapped in half.There was no patient injury.The case was completed with a new device.Product is available for return.Additional information received on 10aug2022 via phone call from user facility: incomplete (7/8) break occurred in middle of cannula after placing instrument through cannula.The break did not fragment.The trocar was inserted normally with no difficulty during insertion.Type of intervention: the case was completed with a new applied trocar.Patient status: no patient injury.

• Brand Name: CTF33, 11X100 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: 15241394
• Report Number: 2027111-2022-00704
• Device Sequence Number: 14648893
• Product Code: GCJ
• UDI-Device Identifier: 00607915124212
• UDI-Public: (01)00607915124212(17)250525(30)01(10)1449728
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 11/03/2022

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: 05/25/2025
• Device Model Number: CTF33
• Device Catalogue Number: 101219301
• Device Lot Number: 1449728
• Was Device Available for Evaluation?: No
• 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: 08/09/2022
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown