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

Model Number C6001

Device Problems Sticking (1597); Increase in Suction (1604)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/21/2016

Event Type  malfunction  

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.

Event Description

Hepatectomy - "in surgery after half hour, the red button was stuck so that cannot stop suction but the blood unable to draw." type of intervention - unknown.Patient status - "fine".

Manufacturer Narrative

Investigation summary: the event unit was returned for evaluation.Upon visual inspection, engineering observed that the aspiration knob of the returned unit was partially compressed and stuck in the open position.Engineering performed an actuation cycle test and confirmed that the aspiration knob was able to return to the closed position.The likely root cause of the stuck aspiration knob is aspirated material, such as viscous bodily fluid and tissue, becoming embedded in the aspiration port and seal.The aspirated material can increase the friction between the knob and the handpiece.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.Additional information was requested and received.

Event Description

Additional information received via email on july 29, 2016 from (b)(6) - "smoke evacuation feature was not activated.The handpiece or probe was checked after surgery, and opened device to confirm that it is normal.No kinking in the tubing.The pressure setting on the or wall suction was 300 mmhg.".

• Brand Name: C6001, 5MMX33CM PROB/VALV DB, G2, 12/BX
• Type of Device: FHF
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: jennifer scoullar ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497133904
• MDR Report Key: 5784391
• MDR Text Key: 49234156
• Report Number: 2027111-2016-00512
• Device Sequence Number: 1
• Product Code: FHF
• UDI-Device Identifier: 00607915116989
• UDI-Public: (01)00607915116989(17)171104(30)01(10)1258423
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K003443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/04/2017
• Device Model Number: C6001
• Device Catalogue Number: 101471030
• Device Lot Number: 1258423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1