MAUDE Adverse Event Report: COOK ENDOSCOPY SAVARY-GILLIARD DILATOR SET

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/26/2007

Event Type  Injury  

Manufacturer Narrative

Usage of device is unknown.Piotet, e., escher, a., & monnier, p.(2007).Esophageal and pharyngeal strictures: report on 1,862 endoscopic dilatations using the savary-gilliard technique.European archives of oto-rhino-laryngology, 265(3), 357¿364.Doi: 10.1007/s00405-007-0456-0.This investigation is on-going.Once complete, a follow-up emdr report will be provided.

Event Description

Cook endoscopy was notified of events that occurred with two (2) savary-gilliard dilator sets.Please see below for relevant excerpts of this article."our database was reviewed to assess number and etiologies of the pharyngeal and esophageal strictures necessitating dilatation in our department between january 1, 1963 and december 31, 2005.Dilatations with the savary-gilliard dilators have been exclusively used in our clinic since 1980, rather than using the maloney dilators or the eder- puestow olives, except for some cases of achalasia that were managed by balloon dilatation.The savary-gilliard set included a metallic guide-wire and polyvinyl chloride bougies, ranging from 5 to 18 mm in diameter.The procedure has been described in detail elsewhere [26], and was always performed under fluoroscopy.Severe complications included esophageal perforation in 34 patients (1.83%), all but one presenting with malignant strictures, and massive bleeding was documented in two patients (0.11%) [subject of this report].Two cases of massive bleeding were reported over the 26-year period of this series, one for a malignant and another for a benign stricture in a patient treated with anticoagulants." it was not published in the article if a section of the device remained inside the patients' body.The article does not indicate how the massive bleeding was treated, but it is assume hemostasis of more nature was administrated.

Manufacturer Narrative

H8: usage of device is unknown.Piotet, e., escher, a., & monnier, p.(2007).Esophageal and pharyngeal strictures: report on 1,862 endoscopic dilatations using the savary-gilliard technique.European archives of oto-rhino-laryngology, 265(3), 357¿364.Doi: 10.1007/s00405-007-0456-0.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 events that occurred with two (2) savary-gilliard dilator sets.Please see below for relevant excerpts of this article."our database was reviewed to assess number and etiologies of the pharyngeal and esophageal strictures necessitating dilatation in our department between january 1, 1963 and december 31, 2005.Dilatations with the savary-gilliard dilators have been exclusively used in our clinic since 1980, rather than using the maloney dilators or the eder- puestow olives, except for some cases of achalasia that were managed by balloon dilatation.The savary-gilliard set included a metallic guide-wire and polyvinyl chloride bougies, ranging from 5 to 18 mm in diameter.The procedure has been described in detail elsewhere [26], and was always performed under fluoroscopy.Severe complications included esophageal perforation in 34 patients (1.83%), all but one presenting with malignant strictures, and massive bleeding was documented in two patients (0.11%) [subject of this report].Two cases of massive bleeding were reported over the 26-year period of this series, one for a malignant and another for a benign stricture in a patient treated with anticoagulants." it was not published in the article if a section of the device remained inside the patients' body.The article does not indicate how the massive bleeding was treated, but it is assumed hemostasis of some nature was administrated.

• Brand Name: SAVARY-GILLIARD DILATOR SET
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 9224076
• MDR Text Key: 163586695
• Report Number: 1037905-2019-00639
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• 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 Received: 10/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention