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

Model Number	CTS02
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2025
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: laparoscopic salpingectomy.Event description: product obturator broke off in patient.As surgeon was attempting to insert outer sleeve bent.Additional information provided by user facility via email on 20aug2025: all pieces were retrieved from the patient.Piece bent in the middle of shaft; broken in middle of obturator while surgeon was attempting to insert.2 cannulas inserted prior to the third one that broke.The trocar was inserted as it always is.You would need to ask dr [name] if he felt there was any difficulty during insertion.It appeared to be a bit more difficult that the previous 2 trocar insertions, but that's just my observation.Intervention: case resolved by dr [name] retrieving the broken piece from the patient.Patient status: no patient injury indicated.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of obturator shaft fracture.The wall thickness of the cannula shaft near the fracture was measured and met specifications.Based on the condition of the returned unit, it is possible that the reported event was caused by pressure on the obturator from instrument manipulation during the procedure.However, the exact root cause could not be determined.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 salpingectomy.Event description: product obturator broke off in patient.As surgeon was attempting to insert outer sleeve bent.Additional information provided by user facility via email on 20aug2025: all pieces were retrieved from the patient.Piece bent in the middle of shaft; broken in middle of obturator while surgeon was attempting to insert.2 cannulas inserted prior to the third one that broke.The trocar was inserted as it always is.You would need to ask dr [name] if he felt there was any difficulty during insertion.It appeared to be a bit more difficult that the previous 2 trocar insertions, but that's just my observation.Intervention: case resolved by dr [name] retrieving the broken piece from the patient.Patient status: no patient injury indicated.

• 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: 22905349
• Report Number: 2027111-2025-00721
• Device Sequence Number: 21104555
• Product Code: GCJ
• UDI-Device Identifier: 00607915123499
• UDI-Public: (01)00607915123499
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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: CTS02
• Device Catalogue Number: 101477464
• Device Lot Number: 1556669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown