MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES KII BALLOON BLUNT TIP SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C0R47
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation, but lot number is provided.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: laparoscopic left inguinal hernia repair.Event description: the surgeon told me that when he inserted the camera into the kii trocar c0r47, he felt like it was difficult to navigate the camera through the trocar, as it seemed hard to move through the seal.He explained me that prior inserting the camera, he placed a gauze through the trocar and then found difficult to go through.I explained that our trocar have seals that are lubricated in order to facilitate the in and out movement of the camera.He mentioned that possibly going with a gauze can lead to compromise the good seal.Additional information received from an applied medical representative via email on 06jan25: fenestrated handle was confirmed as forceps.Type of intervention: he continue the procedure and did not change the trocar.Patient status: no injury or illness was reported.
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.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.
Event or Problem Description
Procedure performed: laparoscopic left inguinal hernia repair.Event description: the surgeon told me that when he inserted the camera into the kii trocar c0r47, he felt like it was difficult to navigate the camera through the trocar, as it seemed hard to move through the seal.He explained me that prior inserting the camera, he placed a gauze through the trocar and then found difficult to go through.I explained that our trocar have seals that are lubricated in order to facilitate the in and out movement of the camera.He mentioned that possibly going with a gauze can lead to compromise the good seal.Additional information received from an applied medical representative via email on 06jan25: fenestrated handle was confirmed as forceps.Additional information received from an applied medical representative via email on 08jan25: there was no difficulty inserting the obturator into the cannula.There was no difficulty removing the obturator from the cannula.Type of intervention: he continue the procedure and did not change the trocar.Patient status: no injury or illness was reported.

• Brand Name: KII BALLOON BLUNT TIP 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: 21105868
• Report Number: 2027111-2025-00313
• Device Sequence Number: 8782416
• Product Code: GCJ
• UDI-Device Identifier: 00607915116453
• UDI-Public: (01)00607915116453
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K060629
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2025

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 Model Number: C0R47
• Device Catalogue Number: 101477565
• Device Lot Number: 1530316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2024
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LAP FENESTRATED HANDLE [FORCEPS] AND A GAUZE.
• Patient Sex: Unknown