MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFR71, 12X150 KII OPT ADVFIX 6/BX; GCJ

Model Number	CFR71
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return.A follow-up report will be provided upon completion of investigation.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.There is no report of serious injury or death associated with this event.
Event or Problem Description
Robotic sacrolpopexy with mesh and mid-urethral sling -- "the trocar in question fractured and broke near the distal end of the cannula, distal to the balloon.The fractured piece fell inside the patient's abdominal cavity during surgery (unknown at what point this happened).They looked at the trocar with ta laparoscope and realized the piece was gone, at which point they searched for, discovered, and retrieved the broken piece.When it was discovered that the piece was gone toward the end of the case, it took approximately 3-5 minutes to locate the piece and another 8-10 to retrieve it according to staff.The trocar was being used a laparoscope port for the robot at the time, in the usual fashion.No other applied products were being used.Standard robotic instrumentation was being in the other ports." "as stated, neither the staff nor the surgeon has any idea what caused the trocar to fracture or at what point it happened.They only discovered it toward the end of the case.But the patient was not harmed and the piece was successfully retrieved.I was unsuccessful in meeting with [the surgeon], so all information came from the staff, either as told to them by [the surgeon], or by staff present during the procedure.Please send the facility return information as soon as possible." patient status: "piece of fractured trocar was retrieved, no injury resulted.".
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Upon inspection, engineering confirmed the complainant's experience of cannula tip fracture.The root cause of the event is likely the result of external force applied on the cannula in combination with lipid exposure.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.

• Brand Name: CFR71, 12X150 KII OPT ADVFIX 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6130291
• Report Number: 2027111-2016-00838
• Device Sequence Number: 13636086
• Product Code: GCJ
• UDI-Device Identifier: 00607915123031
• UDI-Public: (01)00607915123031(17)190705(30)01(10)1274190
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 05/18/2017

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: 07/05/2019
• Device Model Number: CFR71
• Device Catalogue Number: 101256201
• Device Lot Number: 1274190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/28/2016
• Supplement Report FDA Received Date: 05/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STANDARD ROBOTIC INSTRUMENTATION