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

Model Number	CTR03
Medical Device Problem Code	Optical Distortion (3000)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: unknown.Event description: linked complaints: (b)(4).Communication between applied medical territory manager and cd team member via email on 14oct24: i just received a complaint from a surgeon saying that using cfr03 or ctr03 it is not possible to focus on tissue during penetration, so the very idea of optical trocar is lost.He uses a 5 mm [brand] optical system.He says that he had no problem with a [brand] but only with our devices.Additional information was received by an applied medical representative via patient complaint form on 14oct24: a complaint has come from a surgeon that it is not possible to focus on the tissue using cfr03 or ctr03 with a 5mm [brand] optics.The trocars worked well except the issue with focusing at tissue during penetration and was not taken care of after surgery.Note - this complaint is not regarding a special occasion but a general complaint from the surgeon.Communication between applied medical territory manager and cd team member via email on 15oct24: i finally managed to get hold of the surgeon on phone, and it seems like it is not really a compliant but a solvable issue due to the combination of trocar/camera.First, he is the only surgeon in the hospital using optical first access (the rest is using insufflation needle or minilaparotomy) explaining why they have used the trocars for a decade without any optical issues.Secondly, he has only had problems using a [brand] 5mm angled optics with manual focus but will now try with other brands/models to see if things work differently.The exact problem is that when focusing he cannot turn quite enough to get full focus.(he also had tried with some liquid in the trocar but with no difference.) he thought that maybe there are add-on-lenses to the camera that can change the focus limits ¿ if so that could help.Additional information was received by an applied medical representative via email on 18oct24: please note that there was not a specific event and therefore not a specific date or procedure.When he informed me, it was very unclear, but i started a complaint just in case.When i managed to reach him on the phone, i understood that it was a general complaint (from this surgeon only) ¿ using the [brand]optics during first entrance with a cfr03 or ctr03 he was not able to manually turn the focus knob enough to really reach tissue focus.He said he had tried (not on our advice but on his own) to fill the trocar with liquid (saline?) but with the same result.He managed to safely establish pneumoperitoneum anyway and used the devices during the procedures with no other issues.He will now try other optics to see if the result is the same or not.There was no auto focus the problem was that manual focusing was not possible to reach focus on tissue.As the surgeon explained ¿when turning focus knob to max that is not enough to have focus on tissue, i would need a bit more turning possibility¿.The surgeon confirmed he has the same problem with both models cfr03 and ctr03.Type of intervention: continues the surgery.Patient status: patient is 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.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.A historical trend analysis and review of production records was performed, and no trends were identified.[correction] sections d1.Brand name and g4.Premarket identification have been updated.
Event or Problem Description
Procedure performed: unknown.Event description: linked complaints: (b)(4) (report id: 2027111-2024-1022135735), (b)(4) (report id: 2027111-2024-00882).Communication between applied medical territory manager and cd team member via email on 14oct24: i just received a complaint from a surgeon saying that using cfr03 or ctr03 it is not possible to focus on tissue during penetration, so the very idea of optical trocar is lost.He uses a 5 mm [brand] optical system.He says that he had no problem with a [brand] but only with our devices.Additional information was received by an applied medical representative via patient complaint form on 14oct24: a complaint has come from a surgeon that it is not possible to focus on the tissue using cfr03 or ctr03 with a 5mm [brand] optics.The trocars worked well except the issue with focusing on tissue during penetration and was not taken care of after surgery.Note - this complaint is not regarding a special occasion but a general complaint from the surgeon.Communication between applied medical territory manager and cd team member via email on 15oct24: i finally managed to get hold of the surgeon on phone, and it seems like it is not really a compliant but a solvable issue due to the combination of trocar/camera.First, he is the only surgeon in the hospital using optical first access (the rest is using insufflation needle or minilaparotomy) explaining why they have used the trocars for a decade without any optical issues.Secondly, he has only had problems using a [brand] 5mm angled optics with manual focus but will now try with other brands/models to see if things work differently.The exact problem is that when focusing he cannot turn quite enough to get full focus.(he also had tried with some liquid in the trocar but with no difference.) he thought that maybe there are add-on-lenses to the camera that can change the focus limits ¿ if so, that could help.Additional information was received by an applied medical representative via email on 18oct24: please note that there was not a specific event and therefore not a specific date or procedure.When he informed me, it was very unclear, but i started a complaint just in case.When i managed to reach him on the phone, i understood that it was a general complaint (from this surgeon only) ¿ using the [brand] optics during first entrance with a cfr03 or ctr03 he was not able to manually turn the focus knob enough to really reach tissue focus.He said he had tried (not on our advice but on his own) to fill the trocar with liquid (saline?) but with the same result.He managed to safely establish pneumoperitoneum anyway and used the devices during the procedures with no other issues.He will now try other optics to see if the result is the same or not.There was no auto focus the problem was that manual focusing was not possible to reach focus on tissue.As the surgeon explained ¿when turning focus knob to max that is not enough to have focus on tissue, i would need a bit more turning possibility¿.The surgeon confirmed he has the same problem with both models cfr03 and ctr03.Type of intervention: continues the surgery.Patient status: patient is fine.

• 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: 20510522
• Report Number: 2027111-2024-00881
• Device Sequence Number: 8559455
• Product Code: GCJ
• UDI-Device Identifier: 00607915123482
• UDI-Public: 00607915123482
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2025

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: CTR03
• 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: 10/14/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown