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U.S. Department of Health and Human Services

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

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COOK ENDOSCOPY ACUSNARE POLYPECTOMY SNARE SOFT KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number G22704
Device Problem Failure to Cut (2587)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/21/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation evaluation: our laboratory evaluation of the product said to be involved could not confirm the report for unable to polyp. The device was returned with the snare fully retracted into the tubing. The snare was advanced and retracted using the handle with no issues. During a visual inspection of the device, there were no anomalies. The continuity from the electrical pin to the snare head was tested with an ohm meter and passed. An additional functional test was performed by attaching the active cord to the electrical pin. The active cord connected easily and remained securely connected to the device. The device was connected to a valley lab generator and power was applied. The snare cut simulated tissue as expected. 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: a definitive cause for the reported observation could not be determined because the product said to be involved functioned as intended. A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product. The intended use on the ifu mentions the following: "this device is used with an electrosurgical unit for endoscopic polypectomy. " the instructions for use contain the following information to assist with proper set-up and use of the device: "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. " "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 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 remote. 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 a polypectomy, the physician used a cook acusnare polypectomy snare soft. The snare would not cut through the polyps. 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 NameACUSNARE POLYPECTOMY SNARE SOFT
Type of DeviceKNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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
kaylin davis
4900 bethania station rd
winston-salem, NC 27105
3367440157
MDR Report Key12016291
MDR Text Key267740704
Report Number1037905-2021-00252
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 06/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG22704
Device Catalogue NumberSASMM-1-S
Device Lot NumberW4445640
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/05/2021
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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