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

Model Number	CTF73
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: event description: dr.(b)(6) from (b)(6) performed a cholecystectomy surgery.At the end of the procedure, when he was withdrawing the trocars from the abdominal incision, he suddenly noticed a small piece of the trocar inside the incision.The surgeon removed the piece and only then closed the incision.Other sleeves of the 12x100 trocars (cts22).They were unable to tell me whether this broken trocar is the full trocar ctf73 or the separate sleeve (cts22).I suspect it was the full trocar, as earlier this week, a report from the same hospital was received about two faulty trocars from the same batch.Additional information provided by distributor on (b)(6)2025: the bend/break caused particulation.One piece of the sleeve, where the funnel is connected, was broken.A pic was taken.Yes, all pieces were retrieved from the patient.The bend/break took place where the funnel is connected, the side of the sleeve.Shown in the pic.The bend/break was identified during the removal of the trocar at the end of the surgery.The trocar rotated in alternating clockwise and counterclockwise direction during insertion.There was no difficulty during insertion.No, the trocar was not used with a robot.Yes, the obturator was inserted in the cannula at the time of the incident.Additional information received from customer via email on (b)(6)2025: no specific model number was mentioned, it could be ctf73 or cts22.Intervention: the surgeon took out the broken piece by hand.Patient status: okay.
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.
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.Based on the condition of the returned unit; it is possible that the cannula wing tab damage was caused during manufacturing or improper handling of the unit.However, the exact root cause could not be determined.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.
Event or Problem Description
Procedure performed: cholecystectomy surgery.Event description: dr.[name] from [hospital name] performed a cholecystectomy surgery.At the end of the procedure, when he was withdrawing the trocars from the abdominal incision, he suddenly noticed a small piece of the trocar inside the incision.The surgeon removed the piece and only then closed the incision.Other sleeves of the 12x100 trocars (cts22).They were unable to tell me whether this broken trocar is the full trocar ctf73 or the separate sleeve (cts22).I suspect it was the full trocar, as earlier this week, a report from the same hospital was received about two faulty trocars from the same batch.Additional information provided by distributor on 06jan2025: the bend/break caused particulation.One piece of the sleeve, where the funnel is connected, was broken.A pic was taken.Yes, all pieces were retrieved from the patient.The bend/break took place where the funnel is connected, the side of the sleeve.Shown in the pic.The bend/break was identified during the removal of the trocar at the end of the surgery.The trocar rotated in alternating clockwise and counterclockwise direction during insertion.There was no difficulty during insertion.No, the trocar was not used with a robot.Yes, the obturator was inserted in the cannula at the time of the incident.Additional information received from customer via email on 15jan25: no specific model number was mentioned, it could be ctf73 or cts22.Additional information received from an applied medical representative via email on 04feb25: it was confirmed by the distributor that the additional unit received was ctf73 with lot number 1518135.Additional information received from an applied medical representative via email on 08apr25: distributor has confirmed the number of non-event sterile units that will be returning.Intervention: the surgeon took out the broken piece by hand.Patient status: okay.

• 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: 21201275
• Report Number: 2027111-2025-00328
• Device Sequence Number: 7504081
• Product Code: GCJ
• UDI-Device Identifier: 00607915123703
• UDI-Public: (01)00607915123703
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2025

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: CTF73
• Device Catalogue Number: 101219101
• Device Lot Number: 1518135
• 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: 12/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 06/03/2025
• 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
• Patient Sex: Unknown