MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF12, 5X100 KII FIOS ZTHR DP 10/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTF12
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: laparoscopic appendectomy.Event description: obturator tip broke but did not break off ie remained in one piece.The tip broke halfway within the abdominal wall whilst entering - bent tip was visualized laparoscopically hence removed.Surgeon removed damaged trocar and replaced with metal trocar.Product is available for return.Intervention: surgeon removed damaged trocar and replaced with metal trocar.Patient status: no adverse event reported.
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 broken obturator tip.The clear fragment was identified to be a portion of the obturator tip.Based on the condition of the returned unit, it is likely that the reported event was due to excessive force exerted on the unit during insertion.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: laparoscopic appendectomy event description: obturator tip broke but did not break off ie remained in one piece.The tip broke halfway within the abdominal wall whilst entering - bent tip was visualized laparoscopically hence removed.Surgeon removed damaged trocar and replaced with metal trocar.Product is available for return.Additional information received via email 18apr2022 from applied medical representative: one cannula was inserted using the obturator prior to the incident.The break was not considered to be a clean break.The break was jagged, cracked.The trocar was inserted rotating clockwise - rotation was difficult at suprapubic port as the abdominal wall had laxity.Another instrument was used to counter pressure.The surgeon has done this maneuver over 20 times and only this time the obturator became jagged.There was difficulty during insertion.The case was not robotic.Intervention: surgeon removed damaged trocar and replaced with metal trocar.Patient status: no adverse event reported.

• Brand Name: CTF12, 5X100 KII FIOS ZTHR DP 10/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: 14190914
• Report Number: 2027111-2022-00571
• Device Sequence Number: 19972497
• Product Code: GCJ
• UDI-Device Identifier: 00607915125707
• UDI-Public: (01)00607915125707(17)240217(30)01(10)1409297
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2022

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: 02/17/2024
• Device Model Number: CTF12
• Device Catalogue Number: 101062401
• Device Lot Number: 1409297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2022
• Supplement Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 09/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2021
• 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
• Patient Sex: Unknown