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

Model Number	CFF73
Medical Device Problem Codes	Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Procedure performed: superior colon resection: event description: when gauze was inserted and removed during surgery via the trocar in question, a transparent part was found to be missing from the product outside the body.The physician has no experience with similar incidents and is requesting an analysis of the cause of the malfunction.This unit (seal&canula,obturator,syringe) will be returned.Intervention: replaced with cff73 from hospital inventory.Patient status: no patient injury or illness associated with this event.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection of the event unit confirmed the complainant¿s experience of seal component separation.The shield, an internal plastic component of the seal, was fragmented.The fragment was not returned for evaluation.Based on the condition of the returned unit, it is likely that the shield fragmentation was caused by non-axial insertion or removal of asymmetrical instruments through the trocar.Applied medical¿s instructions for use (ifu) states, ¿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.This event was initially reported based on the description of the event.However, based on the evaluation of the returned unit, applied medical determined that this event is not reportable as shield fragmentation is unlikely to cause or contribute to death or serious injury.[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: superior colon resection event description: when gauze was inserted and removed during surgery via the trocar in question, a transparent part was found to be missing from the product outside the body.The physician has no experience with similar incidents and is requesting an analysis of the cause of the malfunction.This unit (seal&canula, obturator, syringe) will be returned.Intervention: replaced with cff73 from hospital inventory.Patient status: no patient injury or illness associated with this event.

• 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: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 19571090
• Report Number: 2027111-2024-00699
• Device Sequence Number: 4057195
• Product Code: GCJ
• UDI-Device Identifier: 00607915117658
• UDI-Public: (01)00607915117658
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2024

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: 06/29/2026
• Device Model Number: CFF73
• Device Catalogue Number: 101245501
• Device Lot Number: 1493744
• 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: 06/06/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2023
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GAUZE, 5MM FORCEPS.
• Patient Sex: Unknown