MAUDE Adverse Event Report: APPLIED MEDICAL C6001, 5MMX33CM PROB/VALV DB, G2, 12/BX; FHF

Model Number	C6001
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has received the incident device and the product has been assigned to engineering for evaluation.A follow-up report will be sent 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
Laparoscopic appendectomy - "in surgery, this device was automatic suction and leak when client did not press the button." patient status - "fine".
Additional Manufacturer Narrative
Investigation summary: the event unit was returned for evaluation.Upon inspection, engineering found no visible damages or defects; however the red knob was turned clockwise to the second level of smoke evacuation.A fluid leak test was performed by actuating the hand piece and running fluid through the tubing, hand piece and probe.No leakages were noted.The root cause of the incident remains unknown as engineering was unable to replicate the event; however, it is possible that the customer experience is due to use error.The instructions for use (ifu) states the blue irrigation button is used to irrigate, and the red suction button to aspirate.The user can activate smoke evacuation by rotating the red suction value clockwise until the desired aspiration level is achieved, and counterclockwise to deactivate smoke evacuation.Although the exact root cause of the event could not be determined, applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.In accordance with 21 cfr 803.56, if we obtain additional information, 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: C6001, 5MMX33CM PROB/VALV DB, G2, 12/BX
• Common Device Name: FHF
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5683819
• Report Number: 2027111-2016-00412
• Device Sequence Number: 413260
• Product Code: FHF
• UDI-Device Identifier: 00607915116989
• UDI-Public: (01)00607915116989(17)170416(30)01(10)1245071
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K003443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2016

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: 04/16/2017
• Device Model Number: C6001
• Device Catalogue Number: 100668401
• Device Lot Number: 1245071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2016
• Supplement Report FDA Received Date: 12/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1