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	05/19/2023
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 the investigation.
Event or Problem Description
Procedure performed: subtotal gastrectomy.Event description: during a robotic surgery, a part of the trocar that they were moving came off and a piece fell inside the patient's abdomen.No one explains why it happened.Nothing has been forced and the team of professionals is used to making this kind of change happen.Information received from applied medical representative via email (b)(6) 2023: no patient injury or illness occurred associated with the complaint event.The patient is ok.The event occurred on (23.Name of procedure being performed is subtotal gastrectomy.The situation was resolved by removing the piece from the patient's abdomen with a grasping forceps.Without any difficulty.All pieces were retrieved from the patient.The customer does not know what instrument was being used at the time it came off, as they did not see it fall out at any time.It was found when checking the abdominal cavity.It is unknown what other instruments were used prior to the incident.No seal components were removed or cut in order to inspect the damaged component, only the part shown in the picture.Type of intervention: the situation was resolved by removing the piece from the patient's abdomen with a grasping forceps.Without any difficulty.Patient status: no patient injury or illness associated with the complaint event.
Additional Manufacturer Narrative
The event unit was not returned to applied medical.However, a photo of the dislodged component was provided.Visual inspection confirmed the complainant¿s experience of seal component separation, as the shield, a clear plastic internal component of the seal, had detached from the seal.Based on the description of the event, it is likely that the reported event was caused by an asymmetrical instrument being inserted or removed through the seal in a non-axial manner.The instructions for use states, ¿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: subtotal gastrectomy.Event description: [translation] during a robotic surgery, a part of the trocar that they were moving came off and a piece fell inside the patient's abdomen.No one explains why it happened.Nothing has been forced and the team of professionals is used to making this kind of change happen.Information received from applied medical representative via email 23may23: no patient injury or illness occurred associated with the complaint event.The patient is ok.The event occurred on (b)(6) 2023.Name of procedure being performed is subtotal gastrectomy.The situation was resolved by removing the piece from the patient's abdomen with a grasping forceps.Without any difficulty.All pieces were retrieved from the patient.The customer does not know what instrument was being used at the time it came off, as they did not see it fall out at any time.It was found when checking the abdominal cavity.It is unknown what other instruments were used prior to the incident.No seal components were removed or cut in order to inspect the damaged component, only the part shown in the picture.Type of intervention: the situation was resolved by removing the piece from the patient's abdomen with a grasping forceps.Without any difficulty.Patient status: ok.

• 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: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 17027828
• Report Number: 2027111-2023-00467
• Device Sequence Number: 12489857
• Product Code: GCJ
• UDI-Device Identifier: 00607915125714
• UDI-Public: (01)00607915125714(17)250928(30)01(10)1464356
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2023

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: 09/28/2025
• Device Model Number: C8701
• Device Catalogue Number: 101473672
• Device Lot Number: 1464356
• 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: 05/22/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GRASPING FORCEPS.
• Patient Sex: Unknown