MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF03, 5X100 KII FIOS Z-THR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTF03
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: lap.Gyn.Procedure.Event description: the sleeve is bent during insertion.Information received from applied medical representative via email 31may2023: no patient issues.The bend/break occurred in the shaft.The trocar was inserted rotated.There was no difficulty during insertion.The break was not considered to be a clean break.It was cracked.The break did not cause particulation.The trocar was not used with a robot.The user used a new trocar.Intervention: the user used a new trocar.Patient status: no patient issues.
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 returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a damaged trocar as both the cannula and obturator were bent.The wall thickness of the cannula and obturator were measured and met specifications.Based on the condition of the returned unit and similar previous incidents, it is likely that the reported event was caused by a high force exerted on the unit during insertion.It is possible that the physical characteristics of the patient contributed to the force exerted on the unit during insertion.This event was initially reported based on the description of the event.However, based on the evaluation of the returned unit, applied medical determined that this event is not reportable as a bent trocar is unlikely to cause or contribute to death or serious injury.
Event or Problem Description
Procedure performed: lap.Gyn.Procedure.Event description: the sleeve is bent during insertion.Information received from applied medical representative via email 31may23: no patient issues.The bend/break occurred in the shaft.The trocar was inserted rotated.There was no difficulty during insertion.The break was not considered to be a clean break.It was cracked.The break did not cause particulation.The trocar was not used with a robot.The user used a new trocar.Intervention: the user used a new trocar.Patient status: no patient issues.

• Brand Name: CTF03, 5X100 KII FIOS Z-THR 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: 17075082
• Report Number: 2027111-2023-00479
• Device Sequence Number: 20522271
• Product Code: GCJ
• UDI-Device Identifier: 00607915123550
• UDI-Public: (01)00607915123550(17)260208(30)01(10)1481023
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2023

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: 02/08/2026
• Device Model Number: CTF03
• Device Catalogue Number: 101472912
• Device Lot Number: 1481023
• 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: 05/31/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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