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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: unknown.Event description: [translation] during placement of the 5 mm trocar, it broke in 2 in the abdominal wall, in horizontal direction.The abdominal wall of the patient was certainly thick, but this should not happen.It was difficult to retrieve the broken piece.Intervention: retrieval of separated part.Patient status: no incidence on the patient status, except the difficulty to take the plastic pieces out.
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.
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 met specifications.Based on the condition of the returned unit and the description of the event, it is likely that the fractured cannula was due to excessive force during use.It is possible that the physical characteristics of the patient contributed to the 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 sleeve gastrectomy.Event description: [translation] during placement of the 5 mm trocar, it broke in 2 in the abdominal wall, in horizontal direction.The abdominal wall of the patient was certainly thick, but this should not happen.It was difficult to retrieve the broken piece.Additional information received by email from applied medical representative on 25jan22: name of procedure being performed => laparoscopic sleeve gastrectomy the part of the device that broke was the cannula.The fracture occurred in the middle of the cannula.Not robot assisted surgery, it was a conventional laparoscopic sleeve gastrectomy the method of insertion was standard : incision of the skin with a scalpel of a 11cm blade, then insertion of the trocar with the obturator.Intervention: retrieval of separated part.Patient status: no incidence on the patient status, excempt the difficulty to take the plastic pieces out.

• 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: 13185203
• Report Number: 2027111-2022-00306
• Device Sequence Number: 2007952
• Product Code: GCJ
• UDI-Device Identifier: 00607915125707
• UDI-Public: (01)00607915125707(17)240826(30)01(10)1424693
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2022

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: 08/26/2024
• Device Model Number: CTF12
• Device Catalogue Number: 101472858
• Device Lot Number: 1424693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2022
• 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: 12/30/2021
• Supplement Date Received by Manufacturer: 12/30/2021
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2021
• 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