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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 AS-1-S
Device Problem Retraction Problem (1536)
Patient Problem No Patient Involvement (2645)
Event Date 07/25/2018
Event Type  malfunction  
Manufacturer Narrative
Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report. The device was returned with the snare head fully extended and the drive wire had disconnected from the handle. During a visual inspection of the drive wire, it appeared that the drive wire had not been torqued. An acusnare from our laboratory stock was disassembled at the handle spool to compare each drive wire. When the drive wire of the laboratory sample device was disconnected from the handle spool, the drive wire at the proximal end had an indention in the wire where the drive wire had been torqued. During the assembly process, the drive wire is placed through a brass insert within the handle spool and is torqued. There was not an indention on the drive wire of the complaint device, indicating most likely that the device was not torqued. The device will be sent back to the supplier. The product was returned to the approved supplier for evaluation and the investigation is on-going. Once additional information has been received, a follow-up emdr report will be provided.
 
Event Description
Prior to a polypectomy, the user selected a cook acusnare polypectomy snare. The user opened the package and checked the integrity of the device. They found out the handle was not working properly and the handle is disconnected from the device. There was no contact with patient. The user used another same product to complete the procedure. The user provided a photo of the device that showed the drive wire was disconnected from the handle. This occurred prior to patient contact; there was no impact to the patient.
 
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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
scottie fariole
4900 bethania station rd
winston-salem, NC 27105
3367440157
MDR Report Key7812997
MDR Text Key118540691
Report Number1037905-2018-00377
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeCN
PMA/PMN Number
K851958
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/26/2021
Device Catalogue NumberAS-1-S
Device Lot NumberW4025642
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/14/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/01/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/26/2018
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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