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

Model Number	CTS22
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: laparoscopic roux-en-y.Event description: complaint description sent to account manager from hospital representative: one of the 12mm trocars broke during the case and could of caused potential harm to the patient.The snap on the one side of the top broke off during the case.I unfortunately don't have the original packaging of this product but all the lot numbers for this product either correlate with either the 12mm with obturator or just the 12mm sleeve.The account manager confirms that one trocar malfunctioned, but the hospital does not know which lot number belonged to the complaint device.The two trocars used in the procedure: 1519454 and 1541901.Additional information obtained from hospital representative on 16may2025: hospital contact confirms that the piece that fell off was "the clip to the white top of the trocar".The piece was retrieved and accounted for.Intervention: new trocar obtained, procedure completed.Patient status: patient is doing well, no issues.
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 not returned to applied medical for evaluation.However, a photograph of the event unit was provided, confirming the complainant¿s experience of a fractured cannula wing tab.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.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: laparoscopic roux-en-y, event description: complaint description sent to account manager from hospital representative: one of the 12mm trocars broke during the case and could of caused potential harm to the patient.The snap on the one side of the top broke off during the case.I unfortunately don't have the original packaging of this product but all the lot numbers for this product either correlate with either the 12mm with obturator or just the 12mm sleeve.The account manager confirms that one trocar malfunctioned, but the hospital does not know which lot number belonged to the complaint device.The two trocars used in the procedure: (b)(6) and (b)(6).Additional information obtained from hospital representative on 16may2025: hospital contact confirms that the piece that fell off was "the clip to the white top of the trocar".The piece was retrieved and accounted for.Intervention: new trocar obtained, procedure completed.Patient status: patient is doing well, no issues.

• 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 ; 9497135359
• MDR Report Key: 22127560
• Report Number: 2027111-2025-00562
• Device Sequence Number: 8669731
• Product Code: GCJ
• UDI-Device Identifier: 00607915123734
• UDI-Public: (01)00607915123734
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2025

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: 101478466
• Device Lot Number: 1541901
• Was Device Available for Evaluation?: No
• 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: 05/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown