MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF03, 5X100 KII FIOS ADVFIX 6/BX; GCJ

Model Number	CFF03
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No response has been received in response to applied medical's request for return of the event product.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: unknown event description: (b)(6).Tip of obturator was passed into the patient and the tip sheared off leaving the tip inside the patients abdomen.Details of injury (to patient, carer or healthcare professional): retrieved tip by making a larger incision.Additional information received via email from sales representative on august 13, 2018: "i've spoken with them and can confirm there wasn't a patient injury." type of intervention: retrieved tip by making a larger incision.Patient status: there wasn't a patient injury.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant¿s experience could not be replicated or confirmed.In the absence of the event unit, it is difficult to determine the exact root cause of the event.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.
Event or Problem Description
Procedure performed: unknown.Event description: (b)(6) reference number: (b)(4).Tip of obturator was passed into the patient and the tip sheared off leaving the tip inside the patients abdomen.Details of injury (to patient, carer or healthcare professional): retrieved tip by making a larger incision.Additional information received via email from sales representative on august 13, 2018: "i've spoken with them and can confirm there wasn't a patient injury." type of intervention: retrieved tip by making a larger incision.Patient status: there wasn't a patient injury.

• Brand Name: CFF03, 5X100 KII FIOS ADVFIX 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7835579
• Report Number: 2027111-2018-00334
• Device Sequence Number: 1535919
• Product Code: GCJ
• UDI-Device Identifier: 00607915117641
• UDI-Public: (01)00607915117641(17)210403(30)01(10)1321255
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2018

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: 04/03/2021
• Device Model Number: CFF03
• Device Catalogue Number: 101221001
• Device Lot Number: 1321255
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 10/16/2018
• Patient Sequence Number: 1