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

Model Number	CTB24
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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: cholecystectomie par coelioscopie.Event description: at the end of the operation (laparoscopic cholecystectomy), when the trocar was removed, the tip broke into several pieces.We had to look for these pieces in the patient's abdomen, hoping they weren't in the wall.We had to put the puzzle back together to check that all the pieces were present." customer added "risk of injury risk of infection from foreign body increased intervention time and use of carbon dioxide insuflation.Additional information received by (b)(4) rep via email on (b)(6) 2024: the obturator was not inside the cannula at the time of the incident not clear break.It shredded in several small pieces.(b)(4) liner was inserted using the trocar before the incident.The trocar was inserted with small rotational movements no difficulties during insertion.Not a robotic case.Intervention: we had to look for these pieces in the patient's abdomen, hoping they weren't in the wall patient status: risk of injury risk of foreign body infection increased intervention time and use of carbon dioxide carbon dioxide insufflation.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with clear fragments.Visual inspection confirmed the complainant¿s experience of a cannula tip fracture.The clear fragments were identified to be part of the cannula tip.Based on the condition of the returned unit, it is likely that the cannula tip was more susceptible to fracture.It is possible that the fracture was due to a force on the cannula tip during the procedure.Applied medical has performed a historical trend analysis and review of production records was performed and no relevant documentation was identified.
Event or Problem Description
Procedure performed: cholecystectomie par coelioscopie.Event description: at the end of the operation (laparoscopic cholecystectomy), when the trocar was removed, the tip broke into several pieces.We had to look for these pieces in the patient's abdomen, hoping they weren't in the wall.We had to put the puzzle back together to check that all the pieces were present." customer added "risk of injury risk of infection from foreign body increased intervention time and use of carbon dioxide insuflation.Additional information received by applied medical rep via email on 5nov24: the obturator was not inside the cannula at the time of the incident not clear break.It shredded in several small pieces.1 liner was inserted using the trocar before the incident.The trocar was inserted with small rotational movements no difficulties during insertion.Not a robotic case.Intervention: we had to look for these pieces in the patient's abdomen, hoping they weren't in the wall patient status: risk of injury risk of foreign body infection increased intervention time and use of carbon dioxide carbon dioxide insufflation.

• Brand Name: KII SHIELDED 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: 20679060
• Report Number: 2027111-2024-00910
• Device Sequence Number: 8557295
• Product Code: GCJ
• UDI-Device Identifier: 00607915126599
• UDI-Public: (01)00607915126599
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2025

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 Expiration Date: 01/05/2026
• Device Model Number: CTB24
• Device Catalogue Number: 101180501
• Device Lot Number: 1477605
• 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: 10/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2023
• 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