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

Model Number	CTF73
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: laparoscopy.Event description: during surgery, trocar model ctf73 broke off inside patient.More information tba.Additional information provided by applied medical representative on 16jul2024 via email: day of surgery: (b)(6) 2024, surgeon name: dr.(b)(6), case being performed: laparoscopy, any injuries to the patient: not at this time during the procedure the trocar was fully intact.Towards the end of the case, it was noticed the tip of the tracar was cracked and a portion of it broke off.Surgeon finished the case by removing the trocar and replacing it with a new one.Additional information provided by applied medical representative on 17jul2024 via email: [hospital] would like to replace the 1 trocar involved along with the remaining 16 sterile trocars with that specific lot number.They would appreciate a return label and a box.Additional information provided by applied medical representative on 24jul2024 via email: no pieces retrieved from the patient.The distal tip of the trocar had a 1-2mm piece broken off.The piece was the clear distal tip.Intervention: removed the trocar and replaced it with a new one.Patient status: no patient injury at this time.
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 returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a cannula tip fracture.Based on the condition of the returned unit, it is possible that the cannula tip fracture was due to instrumentation coming into contact with the tip 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.[correction] sections d1 and d4 (primary unique device identification number and additional unique device identification number) have been updated.
Event or Problem Description
Procedure performed: laparoscopy.Event description: during surgery, trocar model ctf73 broke off inside patient.More information tba.Additional information provided by applied medical representative on 16jul2024 via email: day of surgery: (b)(6) 2024, surgeon name: dr.[name], case being performed: laparoscopy, any injuries to the patient: not at this time during the procedure the trocar was fully intact.Towards the end of the case, it was noticed the tip of the tracar was cracked and a portion of it broke off.Surgeon finished the case by removing the trocar and replacing it with a new one.Additional information provided by applied medical representative on 17jul2024 via email: [hospital] would like to replace the 1 trocar involved along with the remaining 16 sterile trocars with that specific lot number.They would appreciate a return label and a box.Additional information provided by applied medical representative on 24jul2024 via email: no pieces retrieved from the patient.The distal tip of the trocar had a 1-2mm piece broken off.The piece was the clear distal tip.Additional information provided by applied medical representative on 06aug2024 via email: instrumentation used at the time of the incident was the camera port.We were utilizing an [non-applied medical] laparoscope.The laparoscope was the only instrument utilized with this trocar.No internal seal components removed or cut to inspect the damaged component.Intervention: removed the trocar and replaced it with a new one.Patient status: no patient injury at this time.

• 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: 19845709
• Report Number: 2027111-2024-00765
• Device Sequence Number: 6597955
• Product Code: GCJ
• UDI-Device Identifier: 00607915123703
• UDI-Public: (01)00607915123703
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K041795
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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: CTF73
• Device Catalogue Number: 101219101
• Device Lot Number: 1518135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS FLEXIBLE LAPAROSCOPE; TROCAR; TROCAR
• Patient Sex: Unknown