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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK ENDOSCOPY FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL; KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES)
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COOK ENDOSCOPY FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL; KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES) Back to Search Results
Catalog Number FLOW-20-PULL-I-S
Device Problem Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Investigation evaluation: the investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report with further information.
 
Event Description
During a percutaneous endoscopic gastrostomy (peg), the physician used a cook flow 20 percutaneous endoscopic gastrostomy set - pull.The wire loop attached to the dilator on the silicone tube broke after a lot of force was applied to pull the tube through the abdominal wall.This happened on three (3) separate occasions with three (3) separate devices and patients (subject of this report, and see related mdr 1037905-2019-00197 and mdr 1037905-2019-00199).The nurse saw one case and commented that the force used to pull the tube through was unusually excessive.Additional information was received on 03-apr-2019: when pulling the tube through the abdominal wall, excessive force was used/required and the loop broke.The physician felt that the force to pass the tubes was more than normally required, but the clinician was a trainee, so [they had] limited experience.The consultant in attendance thought it was excessive as did the nurses.The feeding tubes were difficult to pass through the incision but not sure why.No sections of the devices remained inside the patient¿s bodies.The patients did not require any additional procedures due to this occurrence.According to the initial reporter, the patients did not experience any adverse effects due to this occurrence.
 
Manufacturer Narrative
Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.Prior to distribution, all flow 20 percutaneous endoscopic gastrostomy sets - pull are subjected to a visual inspection to ensure device integrity.Corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
 
Event Description
During a percutaneous endoscopic gastrostomy (peg), the physician used a cook flow 20 percutaneous endoscopic gastrostomy set - pull.The wire loop attached to the dilator on the silicone tube broke after a lot of force was applied to pull the tube through the abdominal wall.This happened on three (3) separate occasions with three (3) separate devices and patients (subject of this report, and see related mdr 1037905-2019-00197 and mdr 1037905-2019-00199).The nurse saw one case and commented that the force used to pull the tube through was unusually excessive.Additional information was received on 03-apr-2019: when pulling the tube through the abdominal wall, excessive force was used/required and the loop broke.The physician felt that the force to pass the tubes was more than normally required, but the clinician was a trainee, so [they had] limited experience.The consultant in attendance thought it was excessive as did the nurses.The feeding tubes were difficult to pass through the incision but not sure why.No sections of the devices remained inside the patient¿s bodies.The patients did not require any additional procedures due to this occurrence.According to the initial reporter, the patients did not experience any adverse effects due to this occurrence.
 
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Brand Name
FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL
Type of Device
KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES)
Manufacturer (Section D)
COOK ENDOSCOPY
4900 bethania station rd
winston-salem NC 27105
MDR Report Key8510486
MDR Text Key151121218
Report Number1037905-2019-00198
Device Sequence Number1
Product Code KNT
Combination Product (y/n)N
PMA/PMN Number
K920703
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberFLOW-20-PULL-I-S
Was Device Available for Evaluation? No
Date Manufacturer Received04/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ENDOSCOPE - UNKNOWN MAKE AND MODEL.
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