MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTR01, 5X150 KII OPT ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTR01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2023
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: diagnostic laparoscopy.Event description: the blue sleeve of the trocar "snapped in half" during a trocar trial when the surgeon was trying to access the peritoneum.The cannula broke into two pieces with one piece stuck in the subcutaneous layer of the patient's abdominal wall.The obturator was inserted in the cannula at the time of the event and was bent.The break/bend of the cannula and obturator were both at the shaft of the device.No other cannulas were inserted using the obturator prior to the incident.The break of the cannula was considered to be a clean break.The surgeon was able to retrieve all the pieces, and nothing was left behind.The trocar was inserted in a back and forth "windshield wiper" motion.The patient had a high bmi and the surgeon noted great difficulty inserting the trocar.The surgeon had to extend the patient's incision to remove the trocar.No patient injury occurred.Product is available for return.Intervention: the surgeon had to extend the patient's incision to remove the trocar.Patient status: patient is okay.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, photos of the event unit was provided, which confirmed complainant¿s experience of fractured cannula shaft and bent obturator.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported events.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.
Event or Problem Description
Procedure performed: diagnostic laparoscopy.Event description: the blue sleeve of the trocar "snapped in half" during a trocar trial when the surgeon was trying to access the peritoneum.The cannula broke into two pieces with one piece stuck in the subcutaneous layer of the patient's abdominal wall.The obturator was inserted in the cannula at the time of the event and was bent.The break/bend of the cannula and obturator were both at the shaft of the device.No other cannulas were inserted using the obturator prior to the incident.The break of the cannula was considered to be a clean break.The surgeon was able to retrieve all the pieces, and nothing was left behind.The trocar was inserted in a back and forth "windshield wiper" motion.The patient had a high bmi and the surgeon noted great difficulty inserting the trocar.The surgeon had to extend the patient's incision to remove the trocar.No patient injury occurred.Product is available for return.Intervention: the surgeon had to extend the patient's incision to remove the trocar.Patient status: patient is okay.

• Brand Name: CTR01, 5X150 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: 17048117
• Report Number: 2027111-2023-00473
• Device Sequence Number: 14713465
• Product Code: GCJ
• UDI-Device Identifier: 00607915124045
• UDI-Public: (01)00607915124045(17)260102(30)01(10)1477581
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2023

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: 01/02/2026
• Device Model Number: CTR01
• Device Catalogue Number: 101412801
• Device Lot Number: 1477581
• Was Device Available for Evaluation?: No
• 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: 05/23/2023
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TROCARS
• Patient Sex: Unknown