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	06/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: laparascopic diagnostic converted to bilateral salpingo-oopherectomy.Event description: during a laparoscopic gynae case on monday 17th june, it was noticed after the 4th port had been placed, that the trocar tip had broken off.The patient had had previous laparoscopic surgery, so the surgeon thought that this was the reason she was having difficulty in placing the port.Is there a recommendation of how many times each trocar should be used before being replaced.Additional information received from applied medical representative via product complaint form on 20jun24: the trocar was used to insert the 4 ports used for the abdominal surgery.The tip of the trocar was noticed to be missing after the 4 port had been placed into the abdomen.The patient had had previous abdominal surgery and the surgeon did find placing the ports not as straight forward as normal.Once the surgery was completed, the surgeon washed the abdomen out with saline but the tip of the trocar was not found.Additional information received from applied medical representative via email (b)(6) 2024: unfortunately, the specimen was discarded, we have advised the customer to retain any affected specimens for future investigations.Type of intervention: once the surgery was completed, the surgeon washed the abdomen out with saline but the tip of the trocar was not found.Patient status: duty of candour was performed on the patient once they were back on the ward.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, a photograph of the event unit was provided, confirming the complainant¿s experience of a fractured cannula tip.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.A historical trend analysis and review of production records was performed and no relevant documentation was identified.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.Corrections: the brand name in section d1 and the primary/additional di numbers in section d4 have been updated.
Event or Problem Description
Procedure performed: laparoscopic diagnostic converted to bilateral salpingo-oophorectomy.Event description: during a laparoscopic gynae case on monday 17th june, it was noticed after the 4th port had been placed, that the trocar tip had broken off.The patient had previous laparoscopic surgery, so the surgeon thought that this was the reason she was having difficulty in placing the port.Is there a recommendation of how many times each trocar should be used before being replaced.Additional information received from applied medical representative via product complaint form on 20jun2024: the trocar was used to insert the 4 ports used for the abdominal surgery.The tip of the trocar was noticed to be missing after the 4 port had been placed into the abdomen.The patient had previous abdominal surgery and the surgeon did find placing the ports not as straight forward as normal.Once the surgery was completed, the surgeon washed the abdomen out with saline but the tip of the trocar was not found.Additional information received from applied medical representative via email 25jun2024: unfortunately, the specimen was discarded, we have advised the customer to retain any affected specimens for future investigations.Type of intervention: once the surgery was completed, the surgeon washed the abdomen out with saline but the tip of the trocar was not found.Patient status: no patient injury or illness was reported.

• 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: 19611027
• Report Number: 2027111-2024-00712
• Device Sequence Number: 6963678
• Product Code: GCJ
• UDI-Device Identifier: 00607915117641
• UDI-Public: (01)00607915117641
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K083638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2024

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: 1516090
• 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: 06/19/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2024
• 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