MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8701, S ALEXIS LAP SYS W/KII FIOS 5/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C8701
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	10/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: laparoscopic lower anterior resection.Event description: the event occurred during treatment of an unknown procedure.It was not reported how the device was being used or what action was being performed when the event occurred.The duck bill seal fell out into patient.The seal was removed.The surgeon resolved the situation by removing the seal from the patient.It was not reported if other instruments were used when the complaint event occurred.It is unknown if there was any clinical impact to the patient as a result of the event.There is no patient injury or illness associated with the complaint event.The patient status is stable.Additional information was received from field team member on october 25, 2023: name of the procedure performed: laparoscopic lower anterior resection.Date of the event: (b)(6) 2023.Seal fell out as grasper was inserted into port.Surgeon was able to retrieve full seal from patient and examined for any fragments missing.Full seal intact.No clinical impact to patient, and surgeon was confident that this has never previously happened, and that patient was stable.Other instrument being used when the complaint event occurred was grasper.Additional information was received from field team member on october 26, 2023: it was confirmed that the seal they are referring to that fell out was indeed from kii trocar from the alexis lap system.Type of intervention: seal removed from patient.Patient status: there is no patient injury or illness associated with the complaint event.
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.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a clear component.Visual inspection confirmed the complainant¿s experience of shield dislodgment.The clear component was identified to be a shield, an internal plastic component of the seal.Based on the condition of the returned unit, it is likely that the dislodged shield was caused by the non-axial insertion or removal of asymmetrical instruments through the trocar.Applied medical¿s instructions for use (ifu) states that, "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.".Correction: device information was corrected in the section d.Suspect medical device.
Event or Problem Description
Procedure performed: laparoscopic lower anterior resection.Event description: the event occurred during treatment of an unknown procedure.It was not reported how the device was being used or what action was being performed when the event occurred.The duck bill seal fell out into patient.The seal was removed.The surgeon resolved the situation by removing the seal from the patient.It was not reported if other instruments were used when the complaint event occurred.It is unknown if there was any clinical impact to the patient as a result of the event.There is no patient injury or illness associated with the complaint event.The patient status is stable.Additional information was received from field team member on october 25, 2023: name of the procedure performed: laparoscopic lower anterior resection.Date of the event: (b)(6) 2023.Seal fell out as grasper was inserted into port.Surgeon was able to retrieve full seal from patient and examined for any fragments missing.Full seal intact.No clinical impact to patient, and surgeon was confident that this has never previously happened, and that patient was stable.Other instrument being used when the complaint event occurred was grasper.Additional information was received from field team member on october 26, 2023: it was confirmed that the seal they are referring to that fell out was indeed from kii trocar from the alexis lap system.Type of intervention: seal removed from patient.Patient status: there is no patient injury or illness associated with the complaint event.

• Brand Name: C8701, S ALEXIS LAP SYS W/KII FIOS 5/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: 18039940
• Report Number: 2027111-2023-00679
• Device Sequence Number: 12584773
• Product Code: GCJ
• UDI-Device Identifier: 00607915125714
• UDI-Public: (01)00607915125714(17)251031(30)01(10)1469631
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K041795
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2024

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 Expiration Date: 10/31/2025
• Device Model Number: C8701
• Device Catalogue Number: 101473672
• Device Lot Number: 1469631
• 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: 10/18/2023
• Supplement Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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: GRASPER
• Patient Sex: Unknown