MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTR73, 12X100 KII OPT ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTR73
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2024
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 left colectomy event description: hospital: [name] product: ctr73 "towards the end of the surgery, the surgeon (dr.[name]) was pulling out the scope from the ctr73 trocar.When the scope was being pulled out, it was pulled out in a weird angle, which caused the cannula of the trocar to snap in half.They were able to retrieve the trocar pieces." product available for return.Additional information received from applied representative via email on 27mar2024: "break appears to be in the center of the cannula.The break appears to be a clean break.All pieces were accounted for and were retrieved." intervention: the surgery was finished with the same instrument.Patient status: no patient injury.
Additional Manufacturer Narrative
Correction: section b4 "date of this report" of the initial report for 2027111-2024-00493 should state april 4, 2024.This follow-up report was submitted to provide a correction relating to the initial report.
Event or Problem Description
Procedure performed: laparoscopic left colectomy event description: product: ctr73."towards the end of the surgery, the surgeon (dr.[name]) was pulling out the scope from the ctr73 trocar.When the scope was being pulled out, it was pulled out in a weird angle, which caused the cannula of the trocar to snap in half.They were able to retrieve the trocar pieces." product available for return.Additional information received from applied representative via email on 27mar2024: "break appears to be in the center of the cannula.The break appears to be a clean break.All pieces were accounted for and were retrieved." intervention: the surgery was finished with the same instrument.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a fractured cannula shaft.The wall thickness of the cannula shaft near the fracture was measured and did not meet specification.Based on the condition of the returned unit, it is likely that the reported event was due to the uneven wall thickness of the canula.
Event or Problem Description
Procedure performed: laparoscopic left colectomy.Event description: hospital: [name].Product: ctr73."towards the end of the surgery, the surgeon (dr.[name]) was pulling out the scope from the ctr73 trocar.When the scope was being pulled out, it was pulled out in a weird angle, which caused the cannula of the trocar to snap in half.They were able to retrieve the trocar pieces." product available for return.Additional information received from applied representative via email on 27mar2024: "break appears to be in the center of the cannula.The break appears to be a clean break.All pieces were accounted for and were retrieved." intervention: the surgery was finished with the same instrument.Patient status: no patient injury.

• Brand Name: CTR73, 12X100 KII OPT ZTHR 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: 19047682
• Report Number: 2027111-2024-00493
• Device Sequence Number: 7223171
• Product Code: GCJ
• UDI-Device Identifier: 00607915123680
• UDI-Public: (01)00607915123680(17)261214(30)01(10)1506563
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K060096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/17/2024

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 Model Number: CTR73
• Device Catalogue Number: 101219401
• Device Lot Number: 1506563
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 04/05/2024; 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SCOPE
• Patient Sex: Unknown