MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES KII OPTICAL ACCESS SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTR73
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: laparoscopic gastrectomy.Event description: product: 12x100mm kii opt zthr trocar.Before the operation was completed, while attempting to retrieve the specimen, fragments of the trocar were discovered inside the abdominal cavity.The operator has successfully removed the fragments.No impact to the patients.Product available for return: 1 trocar.Additional information received on 24jan2024 via email by distributor: the fragment was from the cannula.The surgery was finished with the same device, since the fragments were only discovered towards the end of the surgery.5mm grasper was used with the trocar (that might have caused the incident).Patient status: no patient injury or illness occurred associated with the complaint event.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a fractured cannula shaft.The wall thickness of the cannula shaft near the fracture was measured and met specifications.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event based on the evaluation of the returned unit.
Event or Problem Description
Procedure performed: laparoscopic gastrectomy.Event description: product: 12x100mm kii opt zthr trocar.Before the operation was completed, while attempting to retrieve the specimen, fragments of the trocar were discovered inside the abdominal cavity.The operator has successfully removed the fragments.No impact to the patients.Product available for return: 1 trocar.Additional information received on 24jan2024 via email by distributor: the fragment was from the cannula.The surgery was finished with the same device, since the fragments were only discovered towards the end of the surgery.5mm grasper was used with the trocar (that might have caused the incident).Patient status: no patient injury or illness occurred associated with the complaint event.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a fractured cannula shaft.However, upon visual inspection, the returned cannula was determined to not be an applied medical cannula and does not belong to any applied medical device.The visual inspection of the event unit confirmed that an applied medical product was not involved in the reported event.Therefore, a product malfunction did not occur with an applied medical product and the event is not reportable.[correction] sections d1 and d4 (primary unique device identification number and additional unique device identification number) have been updated.
Event or Problem Description
Procedure performed: laparoscopic gastrectomy.Event description: product: 12x100mm kii opt zthr trocar.Before the operation was completed, while attempting to retrieve the specimen, fragments of the trocar were discovered inside the abdominal cavity.The operator has successfully removed the fragments.No impact to the patients.Product available for return: 1 trocar.Additional information received on 24jan2024 via email by distributor: the fragment was from the cannula.The surgery was finished with the same device, since the fragments were only discovered towards the end of the surgery.5mm grasper was used with the trocar (that might have caused the incident).Patient status: no patient injury or illness occurred associated with the complaint event.

• Brand Name: KII OPTICAL ACCESS SYSTEM
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 18655833
• Report Number: 2027111-2024-00384
• Device Sequence Number: 20657383
• Product Code: GCJ
• UDI-Device Identifier: 00607915123680
• UDI-Public: (01)00607915123680
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K060096
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2025

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: 10/10/2023
• Device Model Number: CTR73
• Device Catalogue Number: 101219401
• Device Lot Number: 1506561
• 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: 01/23/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 06/04/2024; 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2023
• 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: 5MM GRASPER
• Patient Sex: Unknown