MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF71, 12X150 KII FIOS ADVFIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFF71
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2019
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 investigation.
Event or Problem Description
Procedure performed: laparoscopic robotic assisted hysterectomy.Event description: "refrained fragment" is all of the information provided to me.Additional information received via email on 08jan2020 from [hospital] risk mgmt: the procedure being performed was a laparoscopic robotic assisted hysterectomy.The color of the component was clear.See picture for where fracture occurred.Surgeon was adjusting trocar when the fragmentation occurred.It occurred immediately after reinserting.Pieces did fall into the patient.Missing pieces never found.No information to what instrumentation was being used at the time of the incident.No information to how was the procedure completed.Patient status is pieces never found.The device is not available to return as "we do not release defective items which have been used on a patient." pictures are attached.Patient status: no patient injury.
Additional Manufacturer Narrative
Section h8 was corrected.The event unit was not returned to applied medical for evaluation.However, a photo of the event unit was provided, which confirmed the complainant¿s experience of a cannula tip fracture.Based on the event description and the photo provided, it is likely that the cannula tip fracture was caused by an instrument that came into contact with the cannula during the procedure.However, in the absence of the event unit, it is difficult to determine the exact root cause of the event.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: laparoscopic robotic assisted hysterectomy additional information received via email on 08jan2020 from [hospital] risk mgmt: the procedure being performed was a laparoscopic robotic assisted hysterectomy.The color of the component was clear.See picture for where fracture occurred.Surgeon was adjusting trocar when the fragmentation occurred.It occurred immediately after reinserting.Pieces did fall into the patient.Missing pieces never found.No information to what instrumentation was being used at the time of the incident.No information to how was the procedure completed.Patient status is pieces never found.The device is not available to return as "we do not release defective items which have been used on a patient." pictures are attached.Patient status: no patient injury.

• Brand Name: CFF71, 12X150 KII FIOS ADVFIX 6/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: 9582546
• Report Number: 2027111-2020-00306
• Device Sequence Number: 3389751
• Product Code: GCJ
• UDI-Device Identifier: 00607915123048
• UDI-Public: (01)00607915123048(17)220425(30)01(10)1355919
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,health
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2020

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: 04/25/2022
• Device Model Number: CFF71
• Device Catalogue Number: 101255901
• Device Lot Number: 1355919
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/19/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 02/27/2020
• Patient Sequence Number: 1