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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK ENDOSCOPY ACUSNARE POLYPECTOMY SNARE; FDI, SNARE, FLEXIBLE

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COOK ENDOSCOPY ACUSNARE POLYPECTOMY SNARE; FDI, SNARE, FLEXIBLE Back to Search Results
Model Number G22647
Device Problem Failure to Cut (2587)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/29/2020
Event Type  malfunction  
Manufacturer Narrative
Pma/510(k) #: k191048.Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.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: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.The instructions for use contain the following information to assist with proper setup and use of the device: "before using this device, follow recommendations provided by the electrosurgical unit manufacturer to ensure patient safety through proper selection, placement and utilization of the patient return electrode.Ensure that a proper path from the patient return electrode to the electrosurgical unit is maintained throughout the procedure." prior to distribution, all acusnare polypectomy snares 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 and this represents an isolated occurrence.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.
 
Event Description
During an endoscopic polypectomy, the physician used a cook acusnare polypectomy snare.When they used the device with cautery, it would not cut the tissue until they changed the settings to more of a "coagulation." the snare did not cut on the "blend" setting but cut on the "coag." unknown if the grounding pad may have been in the wrong position.Device did work well enough to complete procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
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Brand Name
ACUSNARE POLYPECTOMY SNARE
Type of Device
FDI, SNARE, FLEXIBLE
Manufacturer (Section D)
COOK ENDOSCOPY
4900 bethania station rd
winston-salem NC 27105
Manufacturer (Section G)
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 Key10920918
MDR Text Key222053364
Report Number1037905-2020-00514
Device Sequence Number1
Product Code FDI
UDI-Device Identifier00827002226470
UDI-Public(01)00827002226470(17)230423(10)W4343222
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 11/30/2020
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
Device Operator Health Professional
Device Expiration Date04/23/2023
Device Model NumberG22647
Device Catalogue NumberASDB-15-015-S
Device Lot NumberW4343222
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/04/2020
Initial Date FDA Received11/30/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/23/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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