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

Model Number	CTS22
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	09/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: laparoscopic right emicolectomy + hepatic metastasectomy.Event description: trocar regularly used for laparoscopic instruments access.After 2 hours of surgery, the procedure required the insertion of a trocar 12x100mm more, using the same obturator as previous one.Once inserted and after a while, the surgeons noticed the presence of a plastic component into the abdominal cavity, once removed they identified it as part of the trocar cannula last inserted.This component is the transparent one which usually stands above the double duck-bill valve and the universal kii valve inside the head of the trocar, like the one in the image attached.Additional info received from an applied medical representative via email on 04oct24: confirmed it was whole component [clear seal].Additional info received from an applied medical representative via email on 10oct24: since the component has been removed from the abdominal cavity as soon as it was noticed, the patient did not report any consequences due to the complaint event.Intervention: the component was removed and the whole trocar replaced.Patient status: the patient did not report any consequences; not any consequences due to the complaint event.
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 returned to applied medical for evaluation, along with a clear component.Visual inspection confirmed the complainant¿s experience of shield dislodgment.The clear component was identified to be a shield, an internal plastic component of the seal.Based on the condition of the returned unit and description of the event, it is likely that the dislodged shield was caused by the non-axial insertion or removal of asymmetrical instruments such as laparoscopic scissors, energy devices, or staples.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 documentation was identified.[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 right emicolectomy + hepatic metastasectomy.Event description: trocar regularly used for laparoscopic instruments access.After 2 hours of surgery, the procedure required the insertion of a trocar 12x100mm more, using the same obturator as previous one.Once inserted and after a while, the surgeons noticed the presence of a plastic component into the abdominal cavity, once removed they identified it as part of the trocar cannula last inserted.This component is the transparent one which usually stands above the double duck-bill valve and the universal kii valve inside the head of the trocar, like the one in the image attached.Additional info received from an applied medical representative via email on 04oct24: confirmed it was whole component [clear seal].Additional info received from an applied medical representative via email on 10oct24: since the component has been removed from the abdominal cavity as soon as it was noticed, the patient did not report any consequences due to the complaint event.Intervention: the component was removed and the whole trocar replaced.Patient status: the patient did not report any consequences; not any consequences due to the complaint event.

• Brand Name: KII SLEEVE
• 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: 20466935
• Report Number: 2027111-2024-00869
• Device Sequence Number: 7236193
• Product Code: GCJ
• UDI-Device Identifier: 00607915123734
• UDI-Public: (01)00607915123734
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 01/14/2025

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: CTS22
• Device Catalogue Number: 101472328
• Device Lot Number: 1525293
• 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: 10/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2024
• 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: 5MM SCISSORS, THUNDERBEAT, SIGNIA STAPLER, OTHERS
• Patient Sex: Unknown