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
Event or Problem Description
Procedure performed: cholecystectomy laparoscopic vs open.Event description: tip of trocar came off upon entry.11/100mm fios first entry.Picture below with details.I was not in procedure.Spoke to dr.And he said he wasn¿t being forceful.Tip of obturator came off in abdomen, and scope pushed through.Was able to retrieve obturator tip laparoscopically.Patient was not injured and doing ok.Hospital has trocar to be returned however nurse did not grab the piece that broke off.Additional information provided by [applied medical representative] on 23apr2026 via email: following up on your questions and speaking directly to [doctor].Zero obturator inserted to another cannula.The only trocar that was used was with that one obturator.Noticed during use.It was identified when the surgeon had trouble inserting and pulled out and tried another spot because was difficult to go in.It was just the scope that was trying to push it¿s way in.Noticed it then and was able to retrieve the tip.Inserted through the tissue layers optically.The difficulty from insertion was because the tip came off.Again, didn¿t notice till pulled out and tried another port site.Intervention: was able to retrieve obturator tip laparoscopically.Patient status: patient was not injured and doing ok.The date of the event is unknown.
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.

• 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: 25033919
• Report Number: 2027111-2026-00526
• Device Sequence Number: 13021592
• Product Code: GCJ
• UDI-Device Identifier: 00607915124212
• UDI-Public: (01)00607915124212
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/29/2026

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 Expiration Date: 06/14/2026
• Device Model Number: CTF33
• Device Catalogue Number: 101219301
• Device Lot Number: 1492334
• 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: 04/22/2026
• Initial Report FDA Received Date: 04/29/2026
• Date Device Manufactured: 06/15/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SCOPE
• Patient Sex: Unknown