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

Model Number	CTF33
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: lap hysterectomy.Event description: i had an incident of seal came off from the trocar(white) while operating.Additional information received from applied medical representative via email 05jul24: updated model number with unknown lot number, procedure as lap hysterectomy, event date.It is the entry pot and when we cleaned the pot with tonsil swab, the entire clear seal came off.Additional information received from applied medical representative via email 11jul24: updated lot number.Intervention: clear plastic shield was retrieved at the end of the procedure.Patient status: stable.
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
A portion of the event unit was returned to applied medical for evaluation.Visual inspection confirmed that the shield, a plastic internal component, dislodged from the seal subassembly.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by an asymmetrical instrument that was inserted through the seal subassembly in a non-axial manner.The instructions for use (ifu) state the following precaution: ¿extra care should be used when inserting angular and asymmetrical instruments, such as ¿j¿ hooks and clip appliers.All instruments should be centered axially when inserted through the seal to prevent tearing¿.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was 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: lap hysterectomy.Event description: i had an incident of seal came off from the trocar (white) while operating.Additional information received from applied medical representative via email 05jul2024: updated model number with unknown lot number, procedure as lap hysterectomy, event date.It is the entry pot and when we cleaned the pot with tonsil swab, the entire clear seal came off.Additional information received from applied medical representative via email 11jul2024: updated lot number.Intervention: clear plastic shield was retrieved at the end of the procedure.Patient status: stable.

• 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: 19851886
• Report Number: 2027111-2024-00763
• Device Sequence Number: 12364466
• Product Code: GCJ
• UDI-Device Identifier: 00607915124212
• UDI-Public: (01)00607915124212
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

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: 1514263
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/29/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2024
• 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: ARTERY FORCEPS CURVED WITH SWAB.; LAPAROSCOPE, JOHANS.
• Patient Sex: Unknown