• Decrease font size
  • Return font size to normal
  • Increase font size
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)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COOK ENDOSCOPY ACUSNARE POLYPECTOMY SNARE KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number G22630
Device Problem Failure to Cut (2587)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 07/20/2021
Event Type  Injury  
Manufacturer Narrative
This investigation is ongoing and a follow up emdr will be sent upon completion.
 
Event Description
During a polypectomy, the physician used two (2) acusnare polypectomy snares. They closed the first snare onto the polyp. They tried to cut with cautery but the cautery would not cut the polyp. Then, the snare would not open for removal. The snare was stuck on the polyp. They tried to use a second snare to cut the polyp and free the first snare, but it had the same problem with both cautery and not reopening and became stuck as well. The patient was sent to surgery for a right hemicolectomy in order to remove the snares and the polyp. A section of the device did not remain inside the patient's body. The patient was sent to surgery for a right hemicolectomy in order to remove the snares and the polyp due to this occurrence.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key12385916
MDR Text Key268792675
Report Number1037905-2021-00457
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,Followup
Report Date 09/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG22630
Device Catalogue NumberASJ-1-S
Device Lot NumberW4319003
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/11/2020
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: 08/30/2021 Patient Sequence Number: 1
Treatment
COVIDIEN ELECTROSURGICAL GENERATOR; OLYMPUS HQ190 ENDOSCOPE
-
-