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

Model Number	CTS22
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
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: unilateral adrenalectomy in prone position.Event description: (b)(4).The trocar broke in the middle part during the operation and was discovered on removal when half of the trocar got stuck in the port hole.It is unclear when during the operation the trocar broke.Two different article numbers are sent in by the customer.The customer will send in 2 art no (cts22 and ctf73) lot no 1525327 and lot no 1514216.Additional information received from an applied medical representative via email on 27sep2024: the tm had spoken with the nurse in charge today earlier to confirm the following - both devices broke during the same procedure on (b)(6)2024.Aware date was updated on 26sep2024 for both complaints.No patient injury and broke piece was retrieved after surgery.Intervention: broke piece was retrieved after surgery.Patient status: no patient injury.
Event or Problem Description
Procedure performed: unilateral adrenalectomy in prone position.Event description: complaint (b)(4) (1 of 2), mfr report number 2027111-2024-00863.Complaint (b)(4) (2 of 2), mfr report number 2027111-2024-00863.The trocar broke in the middle part during the operation and was discovered on removal when half of the trocar got stuck in the port hole.It is unclear when during the operation the trocar broke.Two different article numbers are sent in by the customer.The customer will send in 2 art no (cts22 and ctf73) lot no 1525327 and lot no 1514216.Additional information received from an applied medical representative via email on 27sep24: the applied medical representative had spoken with the nurse in charge today earlier to confirm the following - both devices broke during the same procedure on (b)(6) 24.Aware date was updated on 26 sep 24 for both complaints.No patient injury and broke piece was retrieved after surgery.Additional information received from an applied medical representative via email on 01oct24: no patient was harmed and not a robotic surgery.Intervention: broke piece was retrieved after surgery.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a fractured cannula shaft.The wall thickness of the cannula shaft near the fracture was measured and did not meet specification.Based on the condition of the returned unit, it is likely that the reported event may have occurred during device manipulation after insertion.It is likely that the cannula shaft fracture was due to uneven cannula wall thickness, which could cause the cannula to be more susceptible to fracture.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.[correction] sections d1 and d4 (primary unique device identification number and additional unique device identification number) have been updated.

• Brand Name: KII SLEEVE
• 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 ; 9497138710
• MDR Report Key: 20403277
• Report Number: 2027111-2024-00864
• Device Sequence Number: 3351351
• Product Code: GCJ
• UDI-Device Identifier: 00607915123734
• UDI-Public: (01)00607915123734
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2025

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: CTS22
• Device Catalogue Number: 101472328
• Device Lot Number: 1514216
• 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: 09/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ADVANCED BIPOLAR ENERGY.
• Patient Sex: Unknown