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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK ENDOSCOPY HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC KNQ, DILATOR, ESOPHAGEAL

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COOK ENDOSCOPY HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC KNQ, DILATOR, ESOPHAGEAL Back to Search Results
Catalog Number HBD-W-10-11-12
Device Problems Burst Container or Vessel (1074); Use of Device Problem (1670); Volume Accuracy Problem (1675); Improper or Incorrect Procedure or Method (2017)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 07/16/2018
Event Type  Malfunction  
Manufacturer Narrative

The device has not yet been received and evaluation is pending. A follow-up report will be sent to capture the results of the evaluation.

 
Event Description

During a dilation procedure, the physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic. The dilatation balloon punctured during the procedure. Another device was used [to complete the procedure]. [it was] impossible to test the balloon before use. Additional information regarding patient outcome has been requested, but to date, has not been provided.

 
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Brand NameHERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC
Type of DeviceKNQ, DILATOR, ESOPHAGEAL
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 Key7971332
MDR Text Key126094728
Report Number1037905-2018-00486
Device Sequence Number1
Product Code KNQ
Combination Product (Y/N)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 07/25/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/16/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/19/2020
Device Catalogue NumberHBD-W-10-11-12
Device LOT NumberW3894031
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/18/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/19/2017
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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