MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFS02, 5X100 KII SLEEVE ADVFIX 12/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFS02
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	07/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy.Event description: rep was not present for the case.When the resident inserted the aspiration needle into the trocar the clear seal was pushed through the black seals and into the patient.The black seals were also pushed down into the patient.The pieces were able to be removed.There was no patient injury.The surgeon used another port to complete the procedure.Product is available for return.Additional information was received via email on 19jul2023 from the facility: laparoscopic instruments and a scope were used with the trocar.Yes, internal seal components were cut after the procedure."in order to see where the clear valve came from the outermost black valve was cut after the procedure and removed from the trocar, as well as the inner black valve." type of intervention: the case was completed using another port.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.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy.Event description: rep was not present for the case.When the resident inserted the aspiration needle into the trocar the clear seal was pushed through the black seals and into the patient.The black seals were also pushed down into the patient.The pieces were able to be removed.There was no patient injury.The surgeon used another port to complete the procedure.Product is available for return.Additional information was received via email on 19jul2023 from the facility: laparoscopic instruments and a scope were used with the trocar.Yes, internal seal components were cut after the procedure."in order to see where the clear valve came from the outermost black valve was cut after the procedure and removed from the trocar, as well as the inner black valve." type of intervention: the case was completed using another port.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, photos of the dislodged components were provided.Visual inspection confirmed the complainant¿s experience of seal component separation.The black component was identified to be the septum, an internal rubber component of the seal.The clear component was identified to be the shield, an internal plastic component of the seal.Based on similar events and the provide photos, it is likely that the reported event was caused by 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.".

• Brand Name: CFS02, 5X100 KII SLEEVE ADVFIX 12/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: 17466677
• Report Number: 2027111-2023-00547
• Device Sequence Number: 12571895
• Product Code: GCJ
• UDI-Device Identifier: 00607915117733
• UDI-Public: (01)00607915117733(17)260501(30)01(10)1490710
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K083638
• 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
• Report Date (Section B): 11/13/2023

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: 05/01/2026
• Device Model Number: CFS02
• Device Catalogue Number: 101215501
• Device Lot Number: 1490710
• Was Device Available for Evaluation?: No
• 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: 07/18/2023
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRATION NEEDLE.
• Patient Sex: Unknown