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

Model Number	CTF33
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to be returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: gynecological laparoscopy.Event description: [translation] during gynecological laparoscopy: when the optical trocar was being readjusted for insufflation of the peritoneal cavity, the two lugs snapped off.One of them "jumped" out of the field, the second into the gown and is retained there while still in the patient's abdomen.Withdrawal of equipment and verification of presence of all components.Operative time extended for inspection.Additional information was received by an applied medical representative via product complaint form on 14aug2024: at the end of the procedure, when the reducer was removed to insufflate the abdomen, the two lugs holding the reducer broke cleanly.During a gynecological laparoscopy: when the optical trocar was misadapted for insufflation of the peritoneal cavity, the two lugs broke cleanly.One of them "jumped" off-camera, the second into the shirt and was held there while it was still in the patient's abdomen.Removal of equipment and verification of the presence of all elements.No clinical impact to the patient.Removal of the trocar and recovery of the elements by exploring the abdominal cavity.Extension of operating time for control.Additional information received by an applied medical representative via email on 19aug2024: updated patient status to 'ok'.It was not a robotic case.Type of intervention: removal of the trocar and recovery of the elements by exploring the abdominal cavity.Patient status: ok.
Event or Problem Description
Procedure performed: gynecological laparoscopy.Event description: [translation] during gynecological laparoscopy: when the optical trocar was being readjusted for insufflation of the peritoneal cavity, the two lugs snapped off.One of them "jumped" out of the field, the second into the gown and is retained there while still in the patient's abdomen.Withdrawal of equipment and verification of presence of all components.Operative time extended for inspection.Additional information was received by an applied medical representative via product complaint form on 14aug24: at the end of the procedure, when the reducer was removed to insufflate the abdomen, the two lugs holding the reducer broke cleanly.During a gynecological laparoscopy: when the optical trocar was misadapted for insufflation of the peritoneal cavity, the two lugs broke cleanly.One of them "jumped" off-camera, the second into the shirt and was held there while it was still in the patient's abdomen.Removal of equipment and verification of the presence of all elements.No clinical impact to the patient.Removal of the trocar and recovery of the elements by exploring the abdominal cavity.Extension of operating time for control.Additional information received by an applied medical representative via email on 19aug24: updated patient status to 'ok'.It was not a robotic case.Type of intervention: removal of the trocar and recovery of the elements by exploring the abdominal cavity.Patient status: ok.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a broken cannula wing tab.Based on the condition of the returned unit, it is possible that the damage to the cannula wing tab occurred during manufacturing or due to improper handling.However, the exact root cause of the broken cannula wing tab could not be determined.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.[correction] sections d1 and d4 (primary unique device identification number and additional unique device identification number) have been updated.

• Brand Name: KII FIOS FIRST ENTRY
• 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: 20049632
• Report Number: 2027111-2024-00793
• Device Sequence Number: 7896605
• Product Code: GCJ
• UDI-Device Identifier: 00607915124212
• UDI-Public: (01)00607915124212
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K041795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2025

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: CTF33
• Device Catalogue Number: 101476488
• Device Lot Number: 1519117
• 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: 08/13/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2024
• 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
• Patient Sex: Unknown