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

Model Number	CTR73
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
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 herniorrhaphy.Event description: this morning we have had another 12mm trocar issue with the tab on the side breaking off when [surgeon] was attempting to remove the white cap.No harm occurred to the patient and the broken piece was retrieved.I have the trocar and the packaging and i assume when [healthcare worker] gets back next week she will take a look and then let you have it, [applied representative], but not my decision to make of course.I received this email this morning that said a general surgeon dr.[name] at [hospital] had an issue with a 12mm applied medical trocar.One of the tabs broke off when the surgeon tried removing the seal cap from the trocar.The instrument was saved, and they will need to do their own investigation before allowing the trocar to be released to applied medical.Additional information provided by applied medical representative on 05dec2025: i was not able to speak with the surgeon but was told he said he pinched the tabs to remove the sealing house, and the one side broke.The tab did not fall into the trocar.The surgeon did not have pinch any harder then he normally would.Event happened at the end of the case when the surgeon was taking off the seal housing to rapidly de insufflate abdomen.Yes product was saved, but will be available for return after [hospital] has done their internal investigation.Yes, the latch tab(s) did break and the tabs were being pinched at the time of breakage.One quick change to what i sent you.After speaking with a resident who was in the case.He said the tab did fall into the patients abdomen through the trocar.It was then retrieved and there was no patient injury.Intervention: case was completed patient status: pt.Status was fine with no patient injury.
Event or Problem Description
Procedure performed: laparoscopic herniorrhaphy.Event description: this morning we have had another 12mm trocar issue with the tab on the side breaking off when [surgeon] was attempting to remove the white cap.No harm occurred to the patient and the broken piece was retrieved.I have the trocar and the packaging and i assume when [healthcare worker] gets back next week she will take a look and then let you have it, [applied representative], but not my decision to make of course.I received this email this morning that said a general surgeon dr.[name] at [hospital] had an issue with a 12mm applied medical trocar.One of the tabs broke off when the surgeon tried removing the seal cap from the trocar.The instrument was saved, and they will need to do their own investigation before allowing the trocar to be released to applied medical.Additional information provided by applied medical representative on 05dec2025: i was not able to speak with the surgeon but was told he said he pinched the tabs to remove the sealing house, and the one side broke.The tab did not fall into the trocar.The surgeon did not have pinch any harder than he normally would.Event happened at the end of the case when the surgeon was taking off the seal housing to rapidly de insufflate abdomen.Yes, product was saved but will be available for return after [hospital] has done their internal investigation.Yes, the latch tab(s) did break and the tabs were being pinched at the time of breakage.One quick change to what i sent you.After speaking with a resident who was in the case.He said the tab did fall into the patient's abdomen through the trocar.It was then retrieved and there was no patient injury.Intervention: case was completed.Patient status: pt.Status was fine with no patient injury.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, photographs and videos of the event unit were provided and sterile units from the same lot were returned.The photos and videos confirmed the complainant¿s experience of a fractured wing tab.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.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations 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: 23850687
• Report Number: 2027111-2025-00935
• Device Sequence Number: 9543650
• Product Code: GCJ
• UDI-Device Identifier: 00607915123680
• UDI-Public: (01)00607915123680
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 03/03/2026

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: CTR73
• Device Catalogue Number: 101219401
• Device Lot Number: 1564640
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2025
• 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