MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF73, 12X100 KII FIOS ADVFIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFF73
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	11/09/2022
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 the investigation.
Event or Problem Description
Procedure performed: robot assisted hysterectomy.Event description: the trocar was being used for a robotic assisted hysterectomy.There were multiple laparoscopic instrument changes during the procedure.A clear ring detached from the seal housing and fell into the patient.The piece was retrieved from the patient.The entire clear component fell out.It is unknown what specific instrumentation was being used prior and at the time of the incident.The rep was not present for the case.It is unknown if any internal seal components removed or cut in order to inspect the damaged component."the surgery continued without further incident." no patient injury was reported as a result of the event.Product is available for return.Type of intervention: the surgery continued without further incident.Patient status: no patient injury was reported as a result of the event.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of seal component separation.The shield, an internal plastic component of the seal, had separated from the seal.Based on the condition of the returned unit and the description of the event, 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." this report is to follow up medwatch report #mw5113440.Correction: the initial reporter in section e4 and the report source in section g2 were corrected.
Event or Problem Description
Procedure performed: robot assisted hysterectomy.Event description: the trocar was being used for a robotic assisted hysterectomy.There were multiple laparoscopic instrument changes during the procedure.A clear ring detached from the seal housing and fell into the patient.The piece was retrieved from the patient.The entire clear component fell out.It is unknown what specific instrumentation was being used prior and at the time of the incident.The rep was not present for the case.It is unknown if any internal seal components removed or cut in order to inspect the damaged component."the surgery continued without further incident." no patient injury was reported as a result of the event.Product is available for return.Additional information was received via email regarding medwatch #5113440 on 28nov2022: during the robotic extra fascial radical type i hysterectomy with bilateral salpingo-oophorectomy with lymphatic mapping and lymph node biopsy/sampling, noted that the internal valve came out of the assist port trocar and was inside the abdomen of the patient.The valve removed, inspected and determined to be intact.Fda safety report id #(b)(4).Type of intervention: the surgery continued without further incident.Patient status: no patient injury was reported as a result of the event.

• Brand Name: CFF73, 12X100 KII FIOS ADVFIX 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: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 15839118
• Report Number: 2027111-2022-00830
• Device Sequence Number: 5982748
• Product Code: GCJ
• UDI-Device Identifier: 00607915117658
• UDI-Public: (01)00607915117658(17)250728(30)01(10)1460862
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2023

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: 07/28/2025
• Device Model Number: CFF73
• Device Catalogue Number: 101245501
• Device Lot Number: 1460862
• 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: 11/11/2022
• Supplement Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2022
• 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: LAPAROSCOPIC INSTRUMENTS
• Patient Sex: Unknown