MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFR03, 5X100 KII OPT ADVFIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFR03
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	07/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: laparoscopic total hysterectomy.Event description: the trocar was placed in the patient and during instrument exchange the clear plastic from the seal was pushed down through the trocar and into the patient abdomen.The surgical team noticed the piece on the monitor and retrieved it from the patient.It is unknown which instruments were used at the time of the event.The complaint trocar was replaced with a new trocar.This has occurred a total of two times at this facility.No patient injury.Patient is stable and has been discharged.Product is not available for return.Unit was disposed of by the facility.Additional information received via phone on 04aug2021 from user facility: for both cases the entire clear plastic component fell into the patient.The component fell into the patient during the manipulation of the instruments.During one of the cases, it occurred during the manipulation of a maryland graspers.It is unknown which instrument was being used during the other event.No photos are available of the products.Type of intervention: the clear insert was retrieved from the patient.The trocar was replaced with a new trocar.Patient status: no patient injury, stable and discharged.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.Based on 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.".
Event or Problem Description
Procedure performed: laparoscopic total hysterectomy.Event description: event 1 of 2: report #2027111-2021-00599.Event 2 of 2: report # 2027111-2021-00600.The trocar was placed in the patient and during instrument exchange the clear plastic from the seal was pushed down through the trocar and into the patient abdomen.The surgical team noticed the piece on the monitor and retrieved it from the patient.It is unknown which instruments were used at the time of the event.The complaint trocar was replaced with a new trocar.This has occurred a total of two times at this facility.No patient injury.Patient is stable and has been discharged.Product is not available for return.Unit was disposed of by the facility.Additional information received via phone on 04aug2021 from user facility: for both cases the entire clear plastic component fell into the patient.The component fell into the patient during the manipulation of the instruments.During one of the cases, it occurred during the manipulation of a maryland graspers.It is unknown which instrument was being used during the other event.No photos are available of the products.Type of intervention: the clear insert was retrieved from the patient.The trocar was replaced with a new trocar.Patient status: no patient injury, stable and discharged.

• Brand Name: CFR03, 5X100 KII OPT ADVFIX 6/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: 12297237
• Report Number: 2027111-2021-00600
• Device Sequence Number: 19955762
• Product Code: GCJ
• UDI-Device Identifier: 00607915119881
• UDI-Public: (01)00607915119881(17)240518(30)01(10)1415766
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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 faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2021

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: 05/18/2024
• Device Model Number: CFR03
• Device Catalogue Number: 101221201
• Device Lot Number: 1415766
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 09/21/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MARYLAND GRASPER OR UNKNOWNINSTRUMENT