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

Model Number	C0R37
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	05/05/2025
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 gastric banding.Event description: [translation] patient undergoing laparoscopic gastric banding.When the ring was introduced through the 15mm trocar, the pneumoperitoneum seal topped out and re-entered the abdominal cavity.Clinical consequences and current condition of the patient or person involved - risk of rubber microparticles in the patient's abdominal cavity, they change of trocar damaged the patient's skin.Patient monitoring.Received ansm submitted of incident form on (b)(6) 2025: duplicate was performed and this ansm submission was found to be this complaint.No new information was retrieved.Ansm ref number (b)(4).Additional information received from an applied medical representative via email on 23may25: the changed of the trocar damaged the patient's skin.Patient status, tm to follow up to relevant responsible person.Concomitant device: insertion of a mid gastric band, [device name].Lot number confirmed 1533241.Intervention: change of trocar.Patient status: patient monitoring: no patient injury or illness was reported.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a black fragment and clear component.Visual inspection confirmed the complainant¿s experience of septum fragmentation and shield dislodgment.The black fragment matched the missing portion of the septum, an internal rubber component of the seal.The clear component was identified to be the shield, an internal plastic component of the seal.Based on the condition of the returned unit and description of the event, it is likely the septum fragmentation and shield dislodgement was caused by an asymmetrical instrument that was inserted 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 trends were identified.
Event or Problem Description
Procedure performed: laparoscopic gastric banding.Event description: [translation] patient undergoing laparoscopic gastric banding.When the ring was introduced through the 15mm trocar, the pneumoperitoneum seal topped out and re-entered the abdominal cavity.Clinical consequences and current condition of the patient or person involved - risk of rubber microparticles in the patient's abdominal cavity, they change of trocar damaged the patient's skin.Patient monitoring.Received ansm submitted of incident form on (b)(6) 2025: duplicate was performed and this ansm submission was found to be this complaint.No new information was retrieved.Ansm ref number (b)(4).Additional information received from an applied medical representative via email on 23may25: the changed of the trocar damaged the patient's skin.Patient status, tm to follow up to relevant responsible person.Concomitant device: insertion of a mid gastric band, [device name].Lot number confirmed 1533241.Intervention: change of trocar.Patient status: patient monitoring: no patient injury or illness was reported.

• 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: 22109871
• Report Number: 2027111-2025-00557
• Device Sequence Number: 7276273
• Product Code: GCJ
• UDI-Device Identifier: 00607915116422
• UDI-Public: (01)00607915116422
• 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
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2025

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: C0R37
• Device Catalogue Number: 101414401
• Device Lot Number: 1533241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/09/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2024
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MID GASTRIC BAND, MIDBAND, REF. MID-100M
• Patient Sex: Unknown