MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF14, 5X75 KII FIOS ADVFIX DP 10/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFF14
Medical Device Problem Codes	Material Fragmentation (1261); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit has been returned to applied medical for evaluation.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
Procedure performed: unknown.Event description: in a [age] year-old patient treated for adnexal torsion, when the trocar is used, the tip is bent allowing not its introduction after incision.Clinical consequences: change of introducer.No consequences for the patient.Additional information received by email from the customer on 05may2020: the operation was an adnexal torsion support, the incident was identified when trying to use the device for insertion.The obturator was well in the canula at the time of use.Normal use of the device has been described without the application of excessive force.Intervention: change of introducer.Patient status: no patient injury or illness occurred associated with the complaint event.
Event or Problem Description
Procedure performed: unknown event description: in a [age] year-old patient treated for adnexal torsion, when the trocar is used, the tip is bent allowing not its introduction after incision.Clinical consequences: change of introducer.No consequences for the patient.Additional information received by email from the customer on (b)(6)2020 : the operation was an adnexal torsion support, the incident was identified when trying to use the device for insertion.The obturator was well in the canula at the time of use.Normal use of the device has been described without the application of excessive force.Intervention: change of introducer patient status: no patient injury or illness occurred associated with the complaint event.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a damaged obturator tip.The distal tip of the obturator was fractured, but the fragment was not returned for evaluation.Based on the condition of the returned unit and the description of the event, it is likely that the obturator tip broke due to exposure to lipids and/or material abnormalities during the manufacturing process.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.A bent obturator tip is not considered to be reportable as it is unlikely to cause or contribute to death or serious injury.However, the event is reportable due to the fractured obturator tip that was observed during the evaluation of the returned unit.

• Brand Name: CFF14, 5X75 KII FIOS ADVFIX DP 10/BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 10246623
• Report Number: 2027111-2020-00495
• Device Sequence Number: 18981139
• Product Code: GCJ
• UDI-Device Identifier: 00607915124618
• UDI-Public: (01)00607915124618(17)221121(30)01(10)1371832
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 07/21/2020

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: 11/21/2022
• Device Model Number: CFF14
• Device Catalogue Number: 101473833
• Device Lot Number: 1371832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 07/08/2020
• Supplement Report FDA Received Date: 07/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1