MAUDE Adverse Event Report: APPLIED MEDICAL C7100, EPIX SI CART SET, G2, 12BX; BTA

Model Number	C7100
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/04/2016
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 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.
Event or Problem Description
Laparoscopic cholecystectomy - "suction control stuck in the on position.Unable to disengage the finger control.Suction ran continuously when not being used.Tried pressing both buttons, alternating buttons, prying the button up, and turning pump and suction off and back on with no success.Had used appropriately 500 mls of saline at the point that the button stuck.Ultimately the button did shut off, butt we don't know what fixed it." patient status - "patient was charged for a second device." type of intervention - "a new suction device was opened due to the unreliability of the stuck button.".
Additional Manufacturer Narrative
Customer informed no product return on april 27, 2016.The event unit was not returned to applied medical for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the event.A review of the manufacturing records for the lot number provided revealed that the product passed all quality and manufacturing inspections.During the manufacturing process, all suction irrigation cartridges are thoroughly inspected and tested for functionality and performance prior to packaging.Although the root cause could not be determined, 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.
Event or Problem Description
Laparoscopic cholecystectomy - "suction control stuck in the on position.Unable to disengage the finger control.Suction ran continuously when not being used.Tried pressing both buttons, alternating buttons, prying the button up, and turning pump and suction off and back on with no success.Had used appropriately 500 mls of saline at the point that the button stuck.Ultimately the button did shut off, butt we don't know what fixed it." patient status - "patient was charged for a second device." type of intervention - "a new suction device was opened due to the unreliability of the stuck button." customer experience report - did a patient injury or illness occur that was life threatening: "no"; did incident result in permanent impairment of a body function or permanent damage to a body structure:" no"; was medical or surgical intervention necessary to preclude permanent impairment of a body function or permanent damage to a body structure: "no".

• Brand Name: C7100, EPIX SI CART SET, G2, 12BX
• Common Device Name: BTA
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5488037
• Report Number: 2027111-2016-00199
• Device Sequence Number: 362619
• Product Code: BTA
• UDI-Device Identifier: 00607915127589
• UDI-Public: (01)00607915127589(17)171115(30)01(10)1259332
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K122619
• 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): 12/02/2016

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: 11/15/2017
• Device Model Number: C7100
• Device Catalogue Number: 101471036
• Device Lot Number: 1259332
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2016
• Supplement Report FDA Received Date: 12/02/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1