MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0R37, 15X100 KII OPT ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C0R37
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: laparoscopic robotic procedure.Event description: during laparoscopic robotic procedure rubber interior of 15mm trocar detached into the patient's cavity.The object was removed from the patient, the trocar was removed, and both were assessed.It was confirmed that all parts of the defective trocar were removed from the patient.Additional information provided by facility representative on 20 mar 2024 via email: i did sequester this trochar from the or where the issue occurred.I am able to send it to you for review.I am unsure of the exact attachment that was used during the procedure, but what was described to me was that a rubber flange on the trochar fell off into the surgical field.It was immediately retrieved and exchanged.Type of intervention: the object was removed from the patient, the trocar was removed, and both were assessed.It was confirmed that all parts of the defective trocar were removed from the patient.Patient status: no patient injury.
Additional Manufacturer Narrative
The event device is anticipated to be returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.This report is to follow-up mw # 5152221.
Event or Problem Description
Procedure performed: laparoscopic robotic procedure.Event description: during laparoscopic robotic procedure rubber interior of 15mm trocar detached into the patient's cavity.The object was removed from the patient, the trocar was removed, and both were assessed.It was confirmed that all parts of the defective trocar were removed from the patient.Additional information provided by facility representative on 20mar2024 via email: i did sequester this trochar from the or where the issue occurred.I am able to send it to you for review.I am unsure of the exact attachment that was used during the procedure, but what was described to me was that a rubber flange on the trochar fell off into the surgical field.It was immediately retrieved and exchanged.Type of intervention: the object was removed from the patient, the trocar was removed, and both were assessed.It was confirmed that all parts of the defective trocar were removed from the patient.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection of the event unit confirmed the complainant¿s experience of seal component separation.The septum, an internal rubber component of the seal, was fragmented.Based on the condition of the returned unit, it is likely that the septum fragmentation was caused by non-axial insertion or removal of asymmetrical instruments through the trocar.Applied medical¿s instructions for use (ifu) states, ¿extra care should be used when inserting angular and asymmetrical instruments, such as ¿j¿ hooks and clip appliers.All instruments should be centered axially when inserted through the seal to prevent tearing.¿ 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 septum fragmentation is unlikely to cause or contribute to death or serious injury.This report is to follow-up mw # 5152221.

• Brand Name: C0R37, 15X100 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: 18976072
• Report Number: 2027111-2024-00470
• Device Sequence Number: 6571124
• Product Code: GCJ
• UDI-Device Identifier: 00607915116422
• UDI-Public: (01)00607915116422(17)261030(30)01(10)1506569
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: C0R37
• Device Catalogue Number: 101414401
• Device Lot Number: 1506569
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown