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Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Perforation (2001)
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Event Date 11/01/1993 |
Event Type
Injury
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Manufacturer Narrative
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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).
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Event Description
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Cook endoscopy was notified of an event that occurred with a savary-gilliard wire guide.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 a esophageal perforation.The article did not state if any additional procedures were required for the perforations.
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Manufacturer Narrative
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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.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.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 wire guides 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.
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Event Description
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Cook endoscopy was notified of an event that occurred with a savary-gilliard wire guide.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 a esophageal perforation.The article did not state if any additional procedures were required for the perforations.
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Search Alerts/Recalls
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