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

Model Number	CTR22
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	10/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: laparoscopic nissen fundoplication event description: a transparent part of the trocar reducer has become detached from the trocar head.Changed trocar.Additional information received from applied medical representative via email on 28oct25: the component detached as a piece.It was a transparent part of the double duckbill.It fell into the patient and retrieved.The color was clear transparent.No information regarding instrumentation passed through the event unit(s) during the procedure.No information if any internal seal components removed or cut to inspect the damaged component.Additional information received from applied medical representative via email on 31oct25: a single use kii trocar seal, which is also called reducer as far as i know.Additional information received from applied medical representative via email on 05nov25: procedure: laparoscopic nissen fundoplication.Concomitant device: [competitor brand]5mm grasper, [competitor brand] excel ref x32047.Transparent part of the kii trocar seal detached.No pieces fell into the patient; it stayed inside the trocar sleeve.The color was clear (transparent).[competitor brand] excel ref x32047 instrumentation passed through the event unit(s) during the procedure.The internal seal components were removed or cut to inspect the damaged component.Intervention: device replacement.Patient status: patient is fine.
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.
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 and similar events, it is likely the reported event was caused by an asymmetrical instrument that was inserted through the seal subassembly in a non-axial manner such as a grasper or a suture needle.Applied medical¿s instructions for use (ifu) 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." 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 nissen fundoplication event description: a transparent part of the trocar reducer has become detached from the trocar head.Changed trocar.Additional information received from applied medical representative via email on 28oct25: the component detached as a piece.It was a transparent part of the double duckbill.It fell into the patient and retrieved.The color was clear transparent.No information regarding instrumentation passed through the event unit(s) during the procedure.No information if any internal seal components removed or cut to inspect the damaged component.Additional information received from applied medical representative via email on 31oct25: a single use kii trocar seal, which is also called reducer as far as i know.Additional information received from applied medical representative via email on 05nov25: procedure: laparoscopic nissen fundoplication.Concomitant device: [competitor brand] 5mm grasper, [competitor brand] excel ref x32047.Transparent part of the kii trocar seal detached.No pieces fell into the patient, it stayed inside the trocar sleeve.The color was clear(transparent).[competitor brand] excel ref x32047 instrumentation passed through the event unit(s) during the procedure.The internal seal components were removed or cut to inspect the damaged component.Additional information received from the applied medical customer relations team via email on 15dec25: npr.Intervention: device replacement.Patient status: patient is fine.

• Brand Name: KII LOW PROFILE 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: 23518482
• Report Number: 2027111-2025-00853
• Device Sequence Number: 9769960
• Product Code: GCJ
• UDI-Device Identifier: 00607915126506
• UDI-Public: (01)00607915126506
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2026

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: CTR22
• Device Catalogue Number: 101179901
• Device Lot Number: 1512447
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2024
• 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: ETHICON ETHIBOND EXCEL REF X32047.; MICROFRANCE 5MM GRASPER.
• Patient Sex: Unknown