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

Model Number	CFF33
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: laparoscopic hysterectomy event description: i have received a report about broken trocar.This time from ous - [account name] - id (b)(6).Lot number: 1554010 cff33 kii fos first entry, advanced fixation the nurse reporting the incidence to me by phone today was not in place when the incidence occurred.She received the information the 18th of september.She has not had the opportunity to ask the persons in the operating room about what happened.(b)(6) has been in vacation.As far as she knows, the patient was not harmed by the incidence.They picked up the loose bit of plastic.She will try to collect information from her colleagues monday next week.I will follow her up with answers for questions that i have already written to her in the email.Additional information received from applied medical representative via email on 06oct25: they used clamps to lift the abdominal wall when inserting verres needle.The clamps were still there when inserting the trocar.He said that it might be that the trocar was in conflict with the clamp on its way inside the abdomen.Anyway, they saw the small piece of plastic inside the abdomen when the scope /camera was inserted.There were no other instruments inside the abdomen, only the camera.They picked up the piece of plastic and recognized that it was from the obturator.The cannula was complete without any damage and they continued to work with this in place.The patient was not harmed.Additional information received from applied medical representative via email on 07oct25: i have received information also from the leading nurse about the incidence.She has collected this information from one of the nurses that was in place when it happened: the trocar broke when inserting.The conditions were difficult with fibrotic tissue (and as told earlier, there were clamps nearby).They could hear a ¿click¿ and then searched for the piece of plastic inside the abdomen.They recognized the piece of plastic and took it out immediately.No other instrument was inside the abdomen.The patient was not harmed.Additional information received from applied medical representative via email on 08oct25: this was the first incision and first trocar in the abdomen.The bend/break was identified during insertion.The trocar was inserted by rotating through the tissue layers.There was difficulty during insertion, fibrotic tissue, hard to get through the tissue layers.Intervention: they recognized the piece of plastic and took it out immediately.Patient status: the patient was not harmed.
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 complaint¿s experience of a fractured obturator tip.Based on the condition of the returned unit and description of the event, it is possible that the obturator had prolonged exposure with a heat producing instrument such as the scope.It is also possible the obturator fractured due to higher insertion force.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 hysterectomy.Event description: i have received a report about broken trocar.This time from ous - [account name]: id: (b)(6).Lot number: 1554010.Cff33 kii fos first entry, advanced fixation.The nurse reporting the incidence to me by phone today was not in place when the incidence occurred.She received the information the 18th of september.She has not had the opportunity to ask the persons in the operating room about what happened.She has been in vacation.As far as she knows, the patient was not harmed by the incidence.They picked up the loose bit of plastic.She will try to collect information from her colleagues monday next week.I will follow her up with answers for questions that i have already written to her in the email.Additional information received from applied medical representative via email on 06oct2025: they used clamps to lift the abdominal wall when inserting verres needle.The clamps were still there when inserting the trocar.He said that it might be that the trocar was in conflict with the clamp on its way inside the abdomen.Anyway, they saw the small piece of plastic inside the abdomen when the scope /camera was inserted.There were no other instruments inside the abdomen, only the camera.They picked up the piece of plastic and recognized that it was from the obturator.The cannula was complete without any damage and they continued to work with this in place.The patient was not harmed.Additional information received from applied medical representative via email on 07oct2025: i have received information also from the leading nurse about the incidence.She has collected this information from one of the nurses that was in place when it happened: the trocar broke when inserting.The conditions were difficult with fibrotic tissue (and as told earlier, there were clamps nearby).They could hear a ¿click¿ and then searched for the piece of plastic inside the abdomen.They recognized the piece of plastic and took it out immediately.No other instrument was inside the abdomen.The patient was not harmed.Additional information received from applied medical representative via email on 08oct2025: this was the first incision and first trocar in the abdomen.The bend/break was identified during insertion.The trocar was inserted by rotating through the tissue layers.There was difficulty during insertion, fibrotic tissue, hard to get through the tissue layers.Intervention: they recognized the piece of plastic and took it out immediately.Patient status: the patient was not harmed.

• 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: 23303424
• Report Number: 2027111-2025-00808
• Device Sequence Number: 10192959
• Product Code: GCJ
• UDI-Device Identifier: 00607915119874
• UDI-Public: (01)00607915119874
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K083638
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

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: CFF33
• Device Catalogue Number: 101477566
• Device Lot Number: 1554010
• 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: 10/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CLAMPS AND VERRES NEEDLE.
• Patient Sex: Unknown