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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK ENDOSCOPY SAVARY-GILLIARD DILATOR; KNQ, DILATOR, ESOPHAGEAL
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COOK ENDOSCOPY SAVARY-GILLIARD DILATOR; KNQ, DILATOR, ESOPHAGEAL Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation (2001)
Event Date 11/01/1993
Event Type  Injury  
Manufacturer Narrative
Usage of device is unknown.Swaroop, v., desai, d., mohandas, k., dhir, v., dave, u., gulla, r., dinshaw, k., deshpande, r.And desai, p.(1994).Dilation of esophageal strictures induced by radiation therapy for cancer of the esophagus.Gastrointestinal endoscopy, 40(3), pp.311-315.This investigation is on-going.Once complete, a follow-up emdr report will be provided.(b)(4).
 
Event Description
Cook endoscopy was notified of an event that occurred with savary-gilliard dilator.Please see below for relevant excerpts of this article.¿one hundred three consecutive patients undergoing esophageal dilation for recurrence of dysphagia after external beam radiation therapy (ebrt), intraluminal radiation therapy (ilrt), or a combination of ebrt and ilrt were included in this study.Patients with strictures having sinus tracts, large ulcers, or deeply excavated ulcers and patients with poor performance status (eastern cooperative oncology group [ecog] scale, grade iv) 4 were excluded.Informed consent was obtained from all patients.All the dilations were performed on an ambulatory basis using intravenous analgesia (pentazocine 15 to 30 mg).The dilations were performed using savary-gilliard dilators and guide wires (wilson cook inc., winston-salem, n.C.).The guide wire was placed by three different techniques: (1) endoscopy only, (2) fluoroscopy only, or (3) a combination of endoscopy and fluoroscopy.Dilation without fluoroscopy was restricted to patients with strictures of the upper or middle third of the esophagus in whom pre-dilation assessment had excluded the presence of skip lesions, long tortuous strictures, deep ulcers, blind sinus tracts, hiatal hernia, and deviation of the luminal axis.The complications included continuous severe pain without perforation in 7 patients, esophageal perforation in 1 [subject of this report], suspected esophageal/gastric perforation in 1.Both perforations and the tracheo-esophageal fistula developed in patients in whom dilation was performed using combined fluoroscopy and endoscopy." it was not published in the article if a section of the device remained inside the patient's body.The patient had an esophageal perforation.The article did not state if any additional procedures were required for the perforations.
 
Manufacturer Narrative
H8: usage of device is unknown swaroop, v., desai, d., mohandas, k., dhir, v., dave, u., gulla, r., dinshaw, k., deshpande, r.And desai, p.(1994).Dilation of esophageal strictures induced by radiation therapy for cancer of the esophagus.Gastrointestinal endoscopy, 40(3), pp.311-315.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.The device history record for the lot number said to be involved could not be reviewed because a 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.The instructions for use include the following potential complications "potential complications associated with upper gastrointestinal endoscopy and esophageal dilation include, but are not limited to: perforation, hemorrhage, aspiration, fever, infection, allergic reaction to medication, hypotension, respiratory depression, or arrest, cardiac arrhythmia or arrest.Prior to distribution, all savary-gilliard dilators are subjected to a visual inspection to ensure device integrity.Corrective action: 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
Cook endoscopy was notified of an event that occurred with savary-gilliard dilator.Please see below for relevant excerpts of this article.¿one hundred three consecutive patients undergoing esophageal dilation for recurrence of dysphagia after external beam radiation therapy (ebrt), intraluminal radiation therapy (ilrt), or a combination of ebrt and ilrt were included in this study.Patients with strictures having sinus tracts, large ulcers, or deeply excavated ulcers and patients with poor performance status (eastern cooperative oncology group [ecog] scale, grade iv) 4 were excluded.Informed consent was obtained from all patients.All the dilations were performed on an ambulatory basis using intravenous analgesia (pentazocine 15 to 30 mg).The dilations were performed using savary-gilliard dilators and guide wires (wilson cook inc., winston-salem, n.C.).The guide wire was placed by three different techniques: (1) endoscopy only, (2) fluoroscopy only, or (3) a combination of endoscopy and fluoroscopy.Dilation without fluoroscopy was restricted to patients with strictures of the upper or middle third of the esophagus in whom pre-dilation assessment had excluded the presence of skip lesions, long tortuous strictures, deep ulcers, blind sinus tracts, hiatal hernia, and deviation of the luminal axis.The complications included continuous severe pain without perforation in 7 patients, esophageal perforation in 1 [subject of this report], suspected esophageal/gastric perforation in 1.Both perforations and the tracheo-esophageal fistula developed in patients in whom dilation was performed using combined fluoroscopy and endoscopy." it was not published in the article if a section of the device remained inside the patient's body.The patient had an esophageal perforation.The article did not state if any additional procedures were required for the perforations.
 
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Brand Name
SAVARY-GILLIARD DILATOR
Type of Device
KNQ, DILATOR, ESOPHAGEAL
Manufacturer (Section D)
COOK ENDOSCOPY
4900 bethania station rd
winston-salem NC 27105
MDR Report Key9216275
MDR Text Key176331392
Report Number1037905-2019-00628
Device Sequence Number1
Product Code KNQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 09/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received10/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
COOK SAVARY GILLIARD WIRE GUIDE
Patient Outcome(s) Other;
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