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	Foreign Body In Patient (2687)
Date of Event	02/07/2021
Type of Reportable Event	Malfunction
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 investigation.
Event or Problem Description
Procedure performed: re-laparoscopy for small bowel obstruction.Event description: the blue flange from the port was retained in the subcutaneous tissue of the patient following removal of the port.This was not noted until 5 days after the surgical procedure.Additional information received via email from applied regional sales manager 02mar2021: the patient has been discharged.The component was removed from the patient.They are not aware of any further consequences for the patient.The procedure was performed on (b)(6) 2021.The component was identified on (b)(6) 2021.The initial procedure was an emergency re-laparoscopy for small bowel obstruction - small bowel adherent to pelvic floor mesh.The product is available for return.Type of intervention: the component was removed from the patient.Patient status: the patient has been discharged.The component was removed from the patient.They are not aware of any further consequences for the patient.
Additional Manufacturer Narrative
The retention disk from the event unit was returned to applied medical for evaluation, which confirmed that the retention disc had separated from the trocar.The retention disk was inspected and no non-conformances were found.Based on the evaluation of the returned retention disc and the description of the event, it is likely that the trocar was inserted in a way that the retention disc entered the patient anatomy and the retention disc slid off when the trocar was removed.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: emergency re-laparoscopy for small bowel obstruction.Event description: the blue flange from the port was retained in the subcutaneous tissue of the patient following removal of the port.This was not noted until 5 days after the surgical procedure.Additional information received via email from applied regional sales manager 02mar21: the patient has been discharged.The component was removed from the patient.They are not aware of any further consequences for the patient.The procedure was performed on (b)(6) 2021.The component was identified on (b)(6) 2021.The initial procedure was an emergency re-laparoscopy for small bowel obstruction- small bowel adherent to pelvic floor mesh.The product is available for return.Additional information received via email from applied medical rep 09mar21: the customer will return only the blue flange from the cfs02, retrieved in the patient abdomen, as the rest of the product has been disposed of by customer.Type of intervention: the component was removed from the patient.Patient status: the patient has been discharged.The component was removed from the patient.They are not aware of any further consequences for the patient.

• 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
• MDR Report Key: 11407802
• Report Number: 2027111-2021-00370
• Device Sequence Number: 19975582
• Product Code: GCJ
• UDI-Device Identifier: 00607915117733
• UDI-Public: (01)00607915117733(17)230929(30)01(10)1392885
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2021

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: 09/29/2023
• Device Model Number: CFS02
• Device Catalogue Number: 101472915
• Device Lot Number: 1392885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 05/06/2021
• Patient Sequence Number: 1