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

Model Number	CTR71
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
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 sleeve gastrectomy.Event description: while closing while pulling trocars out the tab connected to seal housing broke off and into the patient.Piece was removed from patient.Another product not deemed necessary.Additional information provided by applied medical representative on 28oct2025: no lot number was provided the latch tab on the cannula broke off and fell into the patient.They were able to retrieve it from the patient.I was not able to get a clear answer on whether the tab was being pinched at the time of breakage.Intervention: piece was removed from patient.Another product not deemed necessary.Patient status: no patient injury indicated.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a broken cannula wing tab.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event based on the evaluation of the returned unit.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.
Event or Problem Description
Procedure performed: laparoscopic sleeve gastrectomy.Event description: while closing while pulling trocars out the tab connected to seal housing broke off and into the patient.Piece was removed from patient.Another product not deemed necessary.Additional information provided by applied medical representative on 28oct2025: no lot number was provided the latch tab on the cannula broke off and fell into the patient.They were able to retrieve it from the patient.I was not able to get a clear answer on whether the tab was being pinched at the time of breakage.Intervention: piece was removed from patient.Another product not deemed necessary.Patient status: no patient injury indicated.

• 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: 23458967
• Report Number: 2027111-2025-00845
• Device Sequence Number: 13054876
• Product Code: GCJ
• UDI-Device Identifier: 00607915125042
• UDI-Public: (01)00607915125042
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2026

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: CTR71
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: SCISSORS, GRASPERS
• Patient Sex: Unknown