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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK ENDOSCOPY ACUSNARE POLYPECTOMY SNARE KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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COOK ENDOSCOPY ACUSNARE POLYPECTOMY SNARE KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Catalog Number ASMH-1-S
Device Problems Off-Label Use (1494); Retraction Problem (1536); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/22/2018
Event Type  malfunction  
Manufacturer Narrative
Investigation evaluation: the four (4) used devices were not included in the return, however sixteen (16) sealed devices from the lot number provided were returned for evaluation. Our laboratory evaluation of the product said to be involved could not confirm the report as it was described. Each of the sixteen (16) sealed devices were tested. Each device functioned as intended. A functional test was performed on each acusnare. Each devices was advanced through an ec-3830 tl pentax colonoscope (2. 8 mm channel). The scope was placed in a curved position to demonstrate a worst case scenario. Once each device was successfully through the distal end of the endoscope, the handle was actuated to test for advancing and retracting of the snare. All sixteen (16) snares opened and closed as intended. Resistance was not encountered when opening and closing the snares. The active cord would connect easily and remained securely connected. The continuity from the electrical pin to the snare head was tested with an ohm meter and passed. The devices were connected to a valley lab generator and power was applied. Each snare cut the simulated tissue as expected. The handle on each device felt smooth during the functional testing. The device history record for the lot number said to be involved was reviewed. A discrepancy or anomaly was not observed with the product that was released for distribution. Investigation conclusion: the additional information provided by the user stated that a cold polypectomy was performed. This is against the intended use of the device. The instructions for use intended use for this device states: "this device is used with an electrosurgical unit for endoscopy polypectomy. Do not use this device for any purpose other than the stated intended use. " this is the most likely cause of the report. The instructions for use contains the following information to assist with proper set-up and use of the device: "visually inspect with particular attention to kinks, bends and breaks. If an abnormality is detected that would prohibit proper working condition, do not use. " "before using this device, follow recommendations provided by electrosurgical unit manufacturer to ensure patient safety through proper placement and utilization of patient return electrode. Ensure a proper path from patient return electrode to electrosurgical unit is maintained throughout the procedure. " "inspect active cord. Cord must be free of kinks, bends, breaks and exposed wires to allow for accurate transfer of current. If an abnormality is noted, do not use active cord. " "with electrosurgical unit off, prepare equipment. Securely connect active cord to device handle and electrosurgical unit. Active cord fittings should fit snugly into both device handle and electrosurgical unit. Following instructions from electrosurgical unit manufacturer, position patient return electrode and connect it to electrosurgical unit. " "fully retract and extend snare to confirm smooth operation of device. " "following electrosurgical unit manufacturer's instructions for settings, verify desired settings and activate electrosurgical unit. Note: maximum rated input voltage for this device is 2kvp-p for cut mode and 5 kvp-p for coagulation mode. " prior to distribution, all acusnare polypectomy snares soft are subjected to a visual inspection and functional testing to ensure device integrity. A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment. Corrective action: a review of the complaint history was conducted. The likelihood of occurrence is considered rare. Corrective action is not warranted at this time based on the quality engineering risk assessment. Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available. Additional comments regarding this report: based on the information provided that the device was used for a cold polypectomy, which is against the intended use, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.
 
Event Description
During a colonoscopy, the physician used four (4) cook acusnare polypectomy snares. While trying to open and snare the polyp, the snare was not coming out [of the sheath]. The physician stated there was difficulty with the handle. When the physician tried to re-snare, the snare did not want to come back in [difficult retraction]. The action of the snare handle was very difficult as not smooth and resulted in not cutting the polyp. The physician finished the procedure with a biopsy forcep. There was no harm to the patient. Additional information was received on 03/07/2018: the snare was hard to open during a polypectomy. When it did come out of the catheter it was hard to close on the polyp. Resistance was felt when opening and closing [the snare]. It happened on several snares after the one used with the same lot number. Additional information was received on 03/16/2018: there was no electrosurgical generators used. It was used to cold snare [cook endoscopy does not manufacture a cold snare, this is therefore off-label use.
 
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Brand NameACUSNARE POLYPECTOMY SNARE
Type of DeviceKNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
COOK ENDOSCOPY
4900 bethania station rd
winston-salem NC 27105
Manufacturer Contact
scottie fariole
4900 bethania station rd
winston-salem, NC 27105
3367440157
MDR Report Key7350826
MDR Text Key103276955
Report Number1037905-2018-00104
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K851958
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 03/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberASMH-1-S
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/22/2018
Device Age2 MO
Event Location Hospital
Date Manufacturer Received02/22/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/14/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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