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

Model Number	CTR73
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2025
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: laproscopic suture gastrorrhaphy with omentum patch.Event description: yes, dr.(b)(6) did have an issue with a trocar.On saturday, (b)(6), dr.(b)(6) was finishing up a laproscopic suture gastrorrhaphy with omentum patch, and when he depressed the clear tabs on each side of the 12mm ctr73 trocar to de-insufflate the abdomen, one of the two clear tabs on the side of the trocar broke off at the point after the reinforcement attaches (at the curve where the tab goes parallel to the trocar) and the broken piece went into the opening of the trocar and into the patient.He found the broken-off piece in the abdomen without difficulty and removed it.There were no negative consequences for the patient that we know of then or thus far.We have the trocar and i believe we also have the broken-off piece, and you tentatively can pick it up wednesday.No other trocar was substituted or used since the procedure was basically finished.Additional information provided by user facility on 04nov2025: the bend/break occurred at the tab.The bend/break was identified during use.The trocar was inserted with rotation.There was no difficulty during insertion.This trocar was not used with a robot.Additional information provided by user facility on 05nov2025 via email: no, the obturator was not inserted in the cannula at the time of the incident.Intervention: he found the broken-off piece in the abdomen without difficulty and removed it.Patient status: there were no negative consequences for the patient that we know of then or thus far.
Event or Problem Description
Procedure performed: laproscopic suture gastrorrhaphy with omentum patch.Event description: yes, dr.[name] did have an issue with a trocar.On saturday, (b)(6) dr.[name] was finishing up a laproscopic suture gastrorrhaphy with omentum patch, and when he depressed the clear tabs on each side of the 12mm ctr73 trocar to de-insufflate the abdomen, one of the two clear tabs on the side of the trocar broke off at the point after the reinforcement attaches (at the curve where the tab goes parallel to the trocar) and the broken piece went into the opening of the trocar and into the patient.He found the broken-off piece in the abdomen without difficulty and removed it.There were no negative consequences for the patient that we know of then or thus far.We have the trocar and i believe we also have the broken-off piece, and you tentatively can pick it up wednesday.No other trocar was substituted or used since the procedure was basically finished.Additional information provided by user facility on 04nov2025: the bend/break occurred at the tab.The bend/break was identified during use.The trocar was inserted with rotation.There was no difficulty during insertion.This trocar was not used with a robot.Additional information provided by user facility on 05nov2025 via email: no, the obturator was not inserted in the cannula at the time of the incident.Intervention: he found the broken-off piece in the abdomen without difficulty and removed it.Patient status: there were no negative consequences for the patient that we know of then or thus far.
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 unit from the same lot was returned.Based on the photograph provided of the event unit, the complainant¿s report of a fractured cannula wing tab was confirmed.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 were 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: 23547067
• Report Number: 2027111-2025-00860
• Device Sequence Number: 9327487
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2026

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: 1562172
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown