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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
Model Number G22630
Device Problems Failure to Conduct (1114); Failure to Cut (2587)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/15/2021
Event Type  malfunction  
Event Description
During a polypectomy, the physician used a cook acusnare polypectomy snare. The user straightened the outer sheath and linked the device with electrosurgical generator, but found out there was no electricity. The user then changed to another electrosurgical generator but still no electricity. 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.
 
Manufacturer Narrative
The device was received for evaluation at the time of this report. A follow up report will be sent to capture the investigation.
 
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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 (Section G)
COOK ENDOSCOPY
4900 bethania station rd
winston-salem NC 27105
Manufacturer Contact
sabrina o'brien
4900 bethania station rd
winston-salem, NC 27105
3367440157
MDR Report Key13501605
MDR Text Key290081193
Report Number1037905-2022-00047
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
PMA/PMN Number
K851958
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG22630
Device Catalogue NumberASJ-1-S
Device Lot NumberW4479175
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/08/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/09/2022 Patient Sequence Number: 1
Treatment
OLYMPUS GIF-0260J ENDOSCOPE
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