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

Catalog Number SGD-18-70

Device Problem Off-Label Use (1494)

Patient Problem Perforation (2001)

Event Type  Injury  

Manufacturer Narrative

Date of event: (b)(6) 2018.(b)(6).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: the information provided indicated this device was used to stretch a lapband at gastro esophageal junction.This is against the intended use of the device and the most likely cause for the reported observation.The intended use in the instructions for use state: "this device is used over a pre-positioned savary-gilliard wire guide for dilation of esophageal strictures." the instructions for use also state: "do not use this device for any purpose other than stated intended use." prior to distribution, all savary-gilliard dilator sets are subjected to a visual inspection to ensure device integrity.Corrective action: a review of the complaint history was conducted and this represents an isolated occurrence.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.Additional comments regarding this report: based on the information provided that this device was used to stretch a lapband at the gastroesophageal junction, against its intended use, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

Event Description

During an endoscopic dilation procedure, the physician used a cook savary-gilliard dilator.An 18 mm savary dilator was used to stretch a lapband at the gastroesophageal junction; a perforation [was] found post procedure.The doctor did not complain of the product being faulty.A section of the device did not remain inside the patient¿s body.The patient did require an additional procedure due to this occurrence.The patient required oesophageal surgery with drain insertion; the patient remained in the hospital.

• Brand Name: SAVARY-GILLIARD DILATOR
• Type of Device: KNQ, DILATOR, ESOPHAGEAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 8121393
• MDR Text Key: 128942437
• Report Number: 1037905-2018-00561
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SGD-18-70
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: COOK SAVARY-GILLIARD WIRE GUIDE, SGW-250-SD
• Patient Outcome(s): Required Intervention