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

Model Number	C0R39
Medical Device Problem Codes	Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: gastric sleeve.Event description: the surgeon was using various applied medical lap instruments through the seal.A piece of silicon from the seal dislodged as the [competitor] gastric stapler.No clinical impact to the patient.The surgeon had to remove the piece of silicon from the patient's abdomen then proceeded to finish the operation.The surgeon asked for another c0r39 and replaced the original one as it was leaking.[competitor] gastric stapler was also used when the complaint even occurred.Intervention: the surgeon had to remove the piece of silicon from the patient's abdomen then proceeded to finish the operation.The surgeon asked for another c0r39 and replaced the original one as it was leaking.Patient status: fine.
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: gastric sleeve.Event description: the surgeon was using various applied medical lap instruments through the seal.A piece of silicon from the seal dislodged as the [competitor] gastric stapler.No clinical impact to the patient.The surgeon had to remove the piece of silicon from the patient's abdomen then proceeded to finish the operation.The surgeon sked for another c0r39 and replaced the original one as it was leaking.[competitor] gastric stapler was also used when the complaint even occurred.Additional information received from applied medical representative on 30jun2025: is there a picture available of the piece? unfortunately, no.Did an entire component fall out or did a piece appear to be torn off? it appeared as if a piece tore off.What color was the piece, black or clear? black.Intervention: the surgeon had to remove the piece of silicon from the patient's abdomen then proceeded to finish the operation.The surgeon asked for another c0r39 and replaced the original one as it was leaking.Patient status: fine.
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 the seal component fragmentation was caused by an asymmetrical instrument that was inserted or removed through the trocar in a non-axial manner.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.¿ applied medical has performed a historical trend analysis and review of production records, and no relevant documentations were identified.This event was initially reported based on the description of the event.However, based on the additional information received, applied medical determined that this event is not reportable as it is unlikely to cause or contribute to death or serious injury.

• 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: 22460147
• Report Number: 2027111-2025-00611
• Device Sequence Number: 15598093
• Product Code: GCJ
• UDI-Device Identifier: 00607915116446
• UDI-Public: (01)00607915116446
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

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: C0R39
• Device Catalogue Number: 101415901
• Device Lot Number: 1533230
• 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: 06/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2024
• 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: METRONIC GASTRIC STAPLER
• Patient Sex: Unknown