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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 G22629
Device Problems Nonstandard Device (1420); Product Quality Problem (1506); Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/13/2021
Event Type  malfunction  
Event Description
In preparation for an endoscopic mucosal resection (emr) in the stomach , the physician selected a cook acusnare polypectomy snare. Initially it was reported that the physician opened the package, checked the device and found that the handle couldn't control the snare. There was no reportable information at this time. Our evaluation of the returned device on 09/01/2021 determined that the handle was broken. The snare was returned extended and could not be retracted [subject of report]. This occurred prior to patient contact; there was no impact to the patient.
 
Manufacturer Narrative
Initial reporter; occupation: unknown. The investigation is on-going. A follow-up emdr will be provided upon completion.
 
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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
MDR Report Key12550062
MDR Text Key281903658
Report Number1037905-2021-00539
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 distributor,foreign
Type of Report Initial,Followup
Report Date 10/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG22629
Device Catalogue NumberAS-1-S
Device Lot NumberW4314401
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/01/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/01/2021
Is This a Reprocessed and Reused Single-Use Device? No

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