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

Model Number	CFF03
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2024
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: found at the end of the surgery.Event description: [translation] the tip of the obturator broke off.During port insertion in connection with a lap ingv hernia, the tip of the obturator broke off.It was used with the optics for optically guided port placement.When i got the obturator/spear back, it was missing the tip.This was found at the end of the surgery in the port hole in the subcutis.Intervention: lap ingv hernia.Patient status: none, as the incident was avoided.
Event or Problem Description
Procedure performed: lap ingv hernia.Event description: [translation] the tip of the obturator broke off.During port insertion in connection with a lap ingv hernia, the tip of the obturator broke off.It was used with the optics for optically guided port placement.When i got the obturator/spear back, it was missing the tip.This was found at the end of the surgery in the port hole in the subcutis.Additional information received from an applied medical representative via customer relation team via email on 24sep24: it was noted by the (b)(6), the customer has thrown out the product.Intervention: found at the end of the surgery.Patient status: none, as the incident was avoided.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.Based on the description of the event, it is possible that the obturator tip may have fractured because of the force of insertion.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 documents were identified.[correction] sections d1 and d4 (primary unique device identification number and additional unique device identification number) have been updated.

• 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: 19867845
• Report Number: 2027111-2024-00769
• Device Sequence Number: 7504237
• Product Code: GCJ
• UDI-Device Identifier: 00607915117641
• UDI-Public: (01)00607915117641
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2024

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 Model Number: CFF03
• Device Catalogue Number: 101473818
• Device Lot Number: 1517350
• Was Device Available for Evaluation?: No
• 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: 07/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown