MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CORPORATION KII® LOW PROFILE OPTICAL ACCESS SYSTEM; LAPAROSCOPE, GENERAL PLASTIC SURGERY

Model Number	CTR22
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Two trocars used during case both with same lot number defective.First trocar broke in two pieces when being placed.Both pieces retrieved and able to be placed together to verify no missing pieces.Second trocar from same lot number also disformed and created a problem causing difficulty advancing instrument through.Both trocars from lot 1522399 ref #ctr22.Two additional trocars opened with different lot numbers that functioned as expected.

• Brand Name: KII® LOW PROFILE OPTICAL ACCESS SYSTEM
• Common Device Name: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES CORPORATION; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 24399961
• Report Number: 24399961
• Device Sequence Number: 18579046
• Product Code: GCJ
• UDI-Device Identifier: 00607915126506
• UDI-Public: (01)00607915126506
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/12/2026
• Report Date (Section F): 02/12/2026

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: CTR22
• Device Lot Number: 1522399
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/20/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Date Report Sent to FDA: 02/12/2026