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	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: cholecystectomy.Event description: [translation] during the introduction of the trocar during a cholecystectomy, the trocar snapped with the obturator.The patient was not injured by this incident.Additional information received by email from applied medical representative on 02oct2020: the fracture did not cause particulation.This port was used as an ancillary port.Method of insertion was normal with the movement "horaire/antihoraire" (clockwise / counterclockwise) kii 5mm.Intervention: the surgeon took another ctf12 trocar afterwards and everything went well.Patient status: no patient injury or illness occurred 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 and obturator.The wall thickness of the cannula shaft and obturator shaft were measured and both met specifications.Based on the condition of the returned unit and the description of the event, it is likely that the cannula and obturator fractured due to a high insertion force that was applied to 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: cholecystectomy event description: [translation] during the introduction of the trocar during a cholecystectomy, the trocar snapped with the obturator.The patient was not injured by this incident.Additional information received by email from applied medical representative on (b)(6) 2020: the fracture did not cause particulation.This port was used as an ancillary port.Method of insertion was normal with the movment "horaire/antihoraire" (clockwise / counterclockwise) kii 5mm intervention: the surgeon took another ctf12 trocar afterwards and everything went well.Patient status: no patient injury or illness occurred associated with the complaint event.
Event or Problem Description
Procedure performed: cholecystectomy.Event description: [translation] during the introduction of the trocar during a cholecystectomy, the trocar snapped with the obturator.The patient was not injured by this incident.Additional information received by email from applied medical representative on 02oct20: the fracture did not cause particulation.This port was used as an ancillary port.Method of insertion was normal with the movement "horaire/antihoraire" (clockwise/counterclockwise) kii 5mm.Intervention: the surgeon took another ctf12 trocar afterwards and everything went well.Patient status: no patient injury or illness occurred associated with the complaint event.
Additional Manufacturer Narrative
Correction: date of event and date of this report were swapped on the initial report.The date of event is (b)(6) 2020.

• 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
• MDR Report Key: 10648902
• Report Number: 2027111-2020-00575
• Device Sequence Number: 2605816
• Product Code: GCJ
• UDI-Device Identifier: 00607915125707
• UDI-Public: (01)00607915125707(17)230324(30)01(10)1382292
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/12/2021

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: 03/24/2023
• Device Model Number: CTF12
• Device Catalogue Number: 101472858
• Device Lot Number: 1382292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 09/29/2020; 09/29/2020
• Initial Report FDA Received Date: 10/08/2020
• Supplement Report FDA Received Date: 11/23/2020; 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1