MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES KII LOW PROFILE BLADED DUAL PACK; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTB23
Medical Device Problem Codes	Nonstandard Device (1420); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: ni.Event description: before using the 5 mm diameter trocar, the surgeon noticed that its mandrel protruded much more than usual from the sleeve.The surgeon refused to use it, considering it dangerous.Alert from the surgeon regarding an anomaly in the length of the laparoscopic trocar mandrel.Abnormally long (a0201).A difference of nearly 1 cm was observed compared to two other batches with the same reference number.Additional information received from an applied medical representative via pcf on 01dec25: he wasn¿t sure whether it was the shirt that was too short or the pyramidal-pointedmandrel that was too long.After checking, they found that only the lot number indicated had this anomaly.Additional information received from an applied medical representative via email on 02dec25: the nurse initially handed the surgeon a trocar which, upon inspection before use, was found to be non-compliant with the type normally used.The nurse then provided a second trocar, which turned out to be identical to the first one.Consequently, the team switched to a different box and lot number to obtain a compliant trocar.The two non-compliant trocars, along with the boxes from the same lot number (approximately 38 units), were returned to the hospital pharmacy.Additional information received by an applied medical representative via email on 12dec25: there were no consequences or injuries.The surgeon identified the anomaly before using the product, which prevented any incident.Intervention: replacement of the trocar - they searched and found another lot number where the trocars appeared to be compliant.
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.Applied medical has issued a voluntary recall for a specific lot, 1546141, of the ctb23, kii low profile bladed trocars and this event is within the scope of the recall.This ctb23 unit is being recalled due to the extended length of the obturator after assembly into the cannula and seal housing.Applied medical has implemented immediate corrections and initiated a corrective and preventative action (capa).
Event or Problem Description
Procedure performed: ni.Event description: before using the 5 mm diameter trocar, the surgeon noticed that its mandrel protruded much more than usual from the sleeve.The surgeon refused to use it, considering it dangerous.Alert from the surgeon regarding an anomaly in the length of the laparoscopic trocar mandrel.Abnormally long (a0201).A difference of nearly 1 cm was observed compared to two other batches with the same reference number.Additional information received from an applied medical representative via pcf on 01dec2025: he wasn¿t sure whether it was the shirt that was too short or the pyramidal-pointedmandrel that was too long.After checking, they found that only the lot number indicated had this anomaly.Additional information received from an applied medical representative via email on 02dec2025: the nurse initially handed the surgeon a trocar which, upon inspection before use, was found to be non-compliant with the type normally used.The nurse then provided a second trocar, which turned out to be identical to the first one.Consequently, the team switched to a different box and lot number to obtain a compliant trocar.The two non-compliant trocars, along with the boxes from the same lot number (approximately 38 units), were returned to the hospital pharmacy.Additional information received by an applied medical representative via email on 12dec2025: there were no consequences or injuries.The surgeon identified the anomaly before using the product, which prevented any incident.Intervention: replacement of the trocar - they searched and found another lot number where the trocars appeared to be compliant.

• Brand Name: KII LOW PROFILE BLADED DUAL PACK
• 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: 23844237
• Report Number: 2027111-2025-00934
• Device Sequence Number: 21232267
• Product Code: GCJ
• UDI-Device Identifier: 00607915126582
• UDI-Public: (01)00607915126582
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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: CTB23
• Device Catalogue Number: 101180401
• Device Lot Number: 1546141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1010-2026
• Patient Sequence Number: 1
• Patient Sex: Unknown