MAUDE Adverse Event Report: COOK ENDOSCOPY SAVARY-GILLIARD DILATOR; KNQ, DILATOR, ESOPHAGEAL

Catalog Number UNKNOWN

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

Patient Problem Perforation of Esophagus (2399)

Event Date 08/23/2011

Event Type  Injury  

Manufacturer Narrative

Usage of device is unknown.Familiari, p., costamagna, g., bléro, d., moine, o.L., perri, v., boskoski, i.Devière, j.(2011).Transoral gastroplasty for morbid obesity: a multicenter trial with a 1-year outcome.Gastrointestinal endoscopy, 74(6), 1248¿1258.Doi: 10.1016/j.Gie.2011.08.046.This investigation is on-going.Once complete, a follow-up emdr report will be provided.

Event Description

Cook endoscopy was notified of an events that occurred with the savary-gilliard dilator.Please see below for relevant excerpts of this article."in an operating room (rome) or anesthesia-equipped endoscopy suite (brussels), patients were positioned supine with shoulders raised by using a positioning pillow.Patients were administered general anesthesia preferably via nasotracheal intubation.Oral tracheal intubation was performed alternatively.Upper gi endoscopy was performed, and a metallic stiff guidewire (savary-gilliard wire guide; cook medical, winston-salem, nc) was passed into the stomach.A 54f then 60f bougie (savary-gilliard dilators; cook medical) was passed to dilate the esophagus and test for resistance.The toga sleeve stapler was passed into the stomach over the guidewire, and a small caliber endoscope (olympus gif p140 or gif xp160 or gif xp180; olympus co, ltd, tokyo, japan) was passed through the device into the stomach for visualization during the procedure (fig.2a).A patient experienced an asymptomatic pneumoperitoneum [indication for perforation] identified on a radiograph before discharge [subject of report].The patient was administered antibiotics and monitored until the condition resolved.No fever or signs of peritonitis were seen." it was not published in the article if a section of the device remained inside the patient¿s body.The patient was administered antibiotics and monitored until the condition resolved.There was no fever or signs of peritonitis.

Manufacturer Narrative

H8: usage of device is unknown.Familiari, p., costamagna, g., bléro, d., moine, o.L., perri, v., boskoski, i., ¿ devière, j.(2011).Transoral gastroplasty for morbid obesity: a multicenter trial with a 1-year outcome.Gastrointestinal endoscopy, 74(6), 1248¿1258.Doi: 10.1016/j.Gie.2011.08.046.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 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 events that occurred with the savary-gilliard dilator.Please see below for relevant excerpts of this article."in an operating room (rome) or anesthesia-equipped endoscopy suite (brussels), patients were positioned supine with shoulders raised by using a positioning pillow.Patients were administered general anesthesia preferably via nasotracheal intubation.Oral tracheal intubation was performed alternatively.Upper gi endoscopy was performed, and a metallic stiff guidewire (savary-gilliard wire guide; cook medical, winston-salem, nc) was passed into the stomach.A 54f then 60f bougie (savary-gilliard dilators; cook medical) was passed to dilate the esophagus and test for resistance.The toga sleeve stapler was passed into the stomach over the guidewire, and a small caliber endoscope (olympus gif p140 or gif xp160 or gif xp180; olympus co, ltd, tokyo, japan) was passed through the device into the stomach for visualization during the procedure (fig.2a)a patient experienced an asymptomatic pneumoperitoneum [indication for perforation] identified on a radiograph before discharge [subject of report].The patient was administered antibiotics and monitored until the condition resolved.No fever or signs of peritonitis were seen." it was not published in the article if a section of the device remained inside the patient¿s body.The patient was administered antibiotics and monitored until the condition resolved.There was no fever or signs of peritonitis.

• 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 Key: 9211138
• MDR Text Key: 169298180
• Report Number: 1037905-2019-00619
• 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: 10/18/2019
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SAVARY-GILLIARD WIRE GUIDE, UNKNOWN MODEL
• Patient Outcome(s): Required Intervention