MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES KII LOW PROFILE OPTICAL DUAL PACK; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTR23
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
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.
Additional Manufacturer Narrative
This medwatch report # 2027111-2024-00900 was a user facility report.Following applied medical¿s submission of the initial report regarding medwatch report # 2027111-2024-00900, applied medical determined that this medwatch report is for the same event that captured in medwatch report # 2027111-2024-00899.Therefore, medwatch report # 2027111-2024-00900 is a duplicate of medwatch report # 2027111-2024-00899.The result of the complainant¿s experience investigation will be documented under medwatch report # 2027111-2024-00899.
Event or Problem Description
Procedure performed: laparoscopic appendicectomy.Event description: a small bit of plastic had broken off the balloon port.Patient status: no patient injury or illness was reported.
Event or Problem Description
Procedure performed: laparoscopic appendicectomy.Event description: a small bit of plastic had broken off the balloon port.Patient status: no patient injury or illness was reported.

• Brand Name: KII LOW PROFILE OPTICAL 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: 20634364
• Report Number: 2027111-2024-00900
• Device Sequence Number: 15330113
• Product Code: GCJ
• UDI-Device Identifier: 00607915126483
• UDI-Public: (01)00607915126483
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 12/20/2024

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: CTR23
• Device Catalogue Number: 101180001
• Device Lot Number: 1511090
• 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: 10/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 12/20/2024
• Date Device Manufactured: 11/30/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown