MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF71, 12X150 KII FIOS ADVFIX 6/BX; GCJ

Model Number	CFF71
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device is anticipated to return.A follow-up report will be provided upon completion of the investigation.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.There is no report of serious injury or death associated with this event.
Event or Problem Description
Robotic hysterectomy - "internal component of the trocar fell out.It was a black rubber piece of the seal which fell into the patient.It was the entire piece that fell out and it was retrieved.Pneumo was restablished." patient status: "ok".Additional information received - june, 7 2016: what instruments were inserted at the time of the incident: passing the suture through the trocar; at what point in the procedure did this occur: end; was there any loss of pneumo: no; if so was it rapid or gradual: no; what type of procedure was performed: robotic hysterectomy.
Additional Manufacturer Narrative
Health professional was correct from yes to no.We have tried to obtain the incident device for evaluation with no success.The event product was not returned to applied medical for evaluation.Based on the description of the event, it is unknown if the customer is referring to the duckbill or septum, both are components of the seal.In the absence of the subject device, it is difficult to determine the root cause of the event.A review of the manufacturing records indicates this lot passed all manufacturing and quality inspections.During the manufacturing process, all trocars are thoroughly inspected for functionality and performance prior to packaging.The root cause of the event is likely due to damage caused by an instrument.As stated in the instructions for use (ifu), "extra care should be used when inserting angular and asymmetrical instruments, such as 'j' hooks and clip appliers.All instruments should be centered axially when inserted through the seal to prevent tearing." although the exact root cause could not be confirmed, 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.In accordance with 21 cfr 803.56, if additional information is obtained which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.

• Brand Name: CFF71, 12X150 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: 5763149
• Report Number: 2027111-2016-00487
• Device Sequence Number: 3539
• Product Code: GCJ
• UDI-Device Identifier: 00607915123048
• UDI-Public: (01)00607915123048(17)170722(30)01(10)1228051
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2017

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: Other
• Device Expiration Date: 07/22/2017
• Device Model Number: CFF71
• Device Catalogue Number: 101289201
• Device Lot Number: 1228051
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2016
• Supplement Report FDA Received Date: 01/25/2017
• Patient Sequence Number: 1