MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTB10, 5X150MM KII BLD DUAL ZTHR 10/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTB10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: bariatric patient.Event description: breakage of the trocar sleeve after placement and during insertion and handling with the instruments.Broken piece recovered from the patient by another trocar.Extended procedure intervention: broken piece recovered from the patient by another trocar.Patient status: no patient injury or illness occur associated with the complaint event.
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, along with the broken piece.Visual inspection confirmed the complainant¿s experience of a fractured cannula.The broken piece completed the missing portion of the cannula.The wall thickness of the cannula was measured and met specifications.Based on the condition of the returned unit, it is likely that the cannula fractured due to excessive force exerted on the unit during the procedure.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: bariatric patient.Event description: breakage of the trocar sleeve after placement and during insertion and handling with the instruments.Broken piece recovered from the patient by another trocar.Extended procedure.Additional information provided by territory manager via email 10aug22: the product is at the hospital pharmacy.The model is ctb10.The break did not cause particulation.The trocar was not used with a robot.Intervention: broken piece recovered from the patient by another trocar.Patient status: no patient injury or illness occur associated with the complaint event.

• Brand Name: CTB10, 5X150MM KII BLD DUAL ZTHR 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: 15189011
• Report Number: 2027111-2022-00689
• Device Sequence Number: 12256669
• Product Code: GCJ
• UDI-Device Identifier: 00607915124007
• UDI-Public: (01)00607915124007(17)230331(30)01(10)1386650
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K072674
• 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): 10/03/2022

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: 03/31/2023
• Device Model Number: CTB10
• Device Catalogue Number: 101417301
• Device Lot Number: 1386650
• 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: 07/26/2022
• Supplement Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 10/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2020
• 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