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

Model Number	CTR03
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product is being returned for evaluation and no lot number has been provided to applied medical.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy.Event description: insufflation tubing was hooked up to 5mm applied medical port.Scope was down a 12mm applied medical port.After losing insufflation, doctor added an additional 12mm [non-applied medical] trocar and insufflation was restored, vessel clipped and bleeding under control.When the instruments are in the new size 5 applied medical trocars and you move insturments around, you are breaking the seal and inherently losing insufflation.Insufflation was lost too quickly and the new trocars do not re-insufflate fast enough.Doctor was unable to apply clips due to lack of insufflation, causing prolonged bleeding while the doctor inserted an additional 12mm port.Dr.Had to put in an additional 12mm port and switch the insufflation tubing to one of the two 12mm trocar ports.Additional information obtained from account manager via email on 28may2025: the patient was stable and recovering well in post-op.450ml blood loss, surgicell was used to stop the bleeding.The doctor reported 100ml blood loss is expected for his typical lap.Choles.Insufflation loss was noted very early in the case when the assist noticed lack of flow from the tower.They originally attributed it to trouble with sedation; additional medication was administered by anestesiologist.When the patient was once again fully sedated, the insufflation issues persisted until the 12mm port was introduced.The insufflation tubing was moved from one 5mm port to another but the problem persisted.Standard instruments i.E scope and grasper were being used down the 5mm ports.Everything appeared to be working at the patient level.Pa and scrub tech checked to ensure the stopcocks were in their correct positions.Intervention: dr.Had to put in an additional 12mm port and switch the insufflation tubing to one of the two 12mm trocar ports.Surgicell was used to top the bleeding.Patient status: prolonged bleeding.The patient was stable and recovering well in post-op.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy.Event description: insufflation tubing was hooked up to 5mm applied medical port.Scope was down a 12mm applied medical port.After losing insufflation, doctor added an additional 12mm [non-applied medical] trocar and insufflation was restored, vessel clipped and bleeding under control.When the instruments are in the new size 5 applied medical trocars and you move insturments around, you are breaking the seal and inherently losing insufflation.Insufflation was lost too quickly and the new trocars do not re-insufflate fast enough.Doctor was unable to apply clips due to lack of insufflation, causing prolonged bleeding while the doctor inserted an additional 12mm port.Dr.Had to put in an additional 12mm port and switch the insufflation tubing to one of the two 12mm trocar ports.Additional information obtained from account manager via email on (b)(6) 2025: the patient was stable and recovering well in post-op.450ml blood loss, surgicell was used to stop the bleeding.The doctor reported 100ml blood loss is expected for his typical lap.Choles.Insufflation loss was noted very early in the case when the assist noticed lack of flow from the tower.They originally attributed it to trouble with sedation; additional medication was administered by anestesiologist.When the patient was once again fully sedated, the insufflation issues persisted until the 12mm port was introduced.The insufflation tubing was moved from one 5mm port to another but the problem persisted.Standard instruments i.E scope and grasper were being used down the 5mm ports.Everything appeared to be working at the patient level.Pa and scrub tech checked to ensure the stopcocks were in their correct positions.Intervention: dr.Had to put in an additional 12mm port and switch the insufflation tubing to one of the two 12mm trocar ports.Surgicell was used to top the bleeding.Patient status: prolonged bleeding.The patient was stable and recovering well in post-op.
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-conformance 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 root cause of the event.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.

• 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: 22171178
• Report Number: 2027111-2025-00577
• Device Sequence Number: 9209029
• Product Code: GCJ
• UDI-Device Identifier: 00607915123482
• UDI-Public: (01)00607915123482
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CTR03
• Device Catalogue Number: 101478496
• 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: 05/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 10/10/2025
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CTR73
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown