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	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: ni.Event description: a problem has been reported concerning a 5 mm laparoscopy trocar composed of two parts: the sharp metal mandrel was too long in relation to the outlet port of the plastic cannula, thus making the batch dangerous.Additional information received by an applied medical representative via email on 10dec25: the product has not been used on the patient.No patient injury occured as a result of this event.How did the user resolve the situation? take a new product.Timing of the event: before the beginning.Questions about blade exposed not applicable for this reference.Did anyone (patient or staff) got injured? no.Patient status: no patient injury or illness was reported.
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 along with nineteen (19) representative units.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.These ctb23 units are 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: a problem has been reported concerning a 5 mm laparoscopy trocar composed of two parts: the sharp metal mandrel was too long in relation to the outlet port of the plastic cannula, thus making the batch dangerous.Additional information received by an applied medical representative via email on 10dec25: the product has not been used on the patient.No patient injury occured as a result of this event.How did the user resolve the situation? take a new product.Timing of the event: before the begining.Questions about blade exposed not applicable for this reference.Did anyone (patient or staff) got injured? no.Patient status: no patient injury or illness was reported.

• 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: 23844280
• Report Number: 2027111-2025-00932
• Device Sequence Number: 13251269
• 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): 04/10/2026

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: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2025
• 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
• 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