MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTR03, 5X100 KII OPT ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTR03
Medical Device Problem Codes	Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2023
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: unknown event description: trocar obturator fell apart as it was in the patient, creating a near miss.Device was not used and a new device was used to complete the case.No patient injury occurred.Device is available for return.Additional information received on 24apr2023 via email from user facility: the clear plastic portion of the obturator separated from the locking cap.One cannula was inserted using the obturator prior to the incident.The break was not considered to be a clean break, there was a jagged small piece.The piece fell into the patient.All pieces were retrieved from the patient.The case was robotic.Intervention: a new device was used to complete the case.Patient status: no patient injury occurred.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Tesing was performed on the event unit which confirmed that the obturator knob was able to be removed from the shaft, no other damages or non-conformances were found.Based on the condition of the returned unit, it is likely that the reported event was caused by non-fills during the manufacturing process.This event was initially reported based on the description of the event.However, based on the evaluation of the returned unit, applied medical determined that this event is not reportable as an obturator knob dislodgement is unlikely to cause or contribute to death or serious injury.
Event or Problem Description
Procedure performed: unknown.Event description: trocar obturator fell apart as it was in the patient, creating a near miss.Device was not used and a new device was used to complete the case.No patient injury occurred.Device is available for return.Additional information received on 24apr2023 via email from user facility: the clear plastic portion of the obturator separated from the locking cap.One cannula was inserted using the obturator prior to the incident.The break was not considered to be a clean break, there was a jagged small piece.The piece fell into the patient.All pieces were retrieved from the patient.The case was robotic.Intervention: a new device was used to complete the case.Patient status: no patient injury occurred.

• Brand Name: CTR03, 5X100 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: 16809165
• Report Number: 2027111-2023-00425
• Device Sequence Number: 2996985
• Product Code: GCJ
• UDI-Device Identifier: 00607915123482
• UDI-Public: (01)00607915123482(17)260116(30)01(10)1477583
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2023

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: 01/16/2026
• Device Model Number: CTR03
• Device Catalogue Number: 101138201
• Device Lot Number: 1477583
• 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: 04/17/2023
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown