MAUDE Adverse Event Report: Wilson-Cook Medical Inc (Cook Endoscopy) SAVARY-GILLIARD DILATOR; Dilator, Esophageal

Model Number	G21383
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During cleaning of a cook savary-gilliard dilator, it was reported that the little metal tip came out.This occurred prior to patient contact; there was no impact to the patient.
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in a red bio bag.The lot number is etched on the side of the device and matches the report.Our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with metal tip taped to the side of the dilator.The distal tip was split and could have contributed to the metal tip being displaced/removed.The device was looked at under magnification, and we can confirm that the distal tip is split and this could be due to the metal cannula coming out of the distal end.The metal cannula was measured and the cannula is within specification but the distal tip of the savary could not be measured due to the split at the distal tip.No other anomalies were detected with the device.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: our evaluation of the device confirmed the report, the metal cannula was measured to be within our manufacturing specification, and the distal tip was split.A definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.The ifu includes the follow precaution: reusability of a device depends, in large part, on care of device by user.Factors involved in prolonging life of this device include but are not limited to: thorough cleaning following instructions provided in this booklet.During cleaning, inspect the integrity and the function of the device to determine advisability of reuse.If kinks, bends or breaks exist do not use.The ifu also includes the following warning: "the maximum service temperature for the dilator is 50c.Exposing the dilator to temperatures greater than 50c may compromise the performance of the device." prior to distribution, all savary-gilliard esophageal dilators are subjected to a visual and functional inspection to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: based on the quality engineering risk assessment no corrective action is warranted at this time.A review of the complaint history was conducted.There have been no other similar occurrences reported during the time period reviewed.Therefore, this report represents an isolated occurrence.Based on this review, the likelihood of this type of report is rare.Quality assurance will continue to monitor for complaint trends.

• Brand Name: SAVARY-GILLIARD DILATOR
• Common Device Name: Dilator, Esophageal
• Manufacturer (Section D): Wilson-Cook Medical Inc (Cook Endoscopy); 4900 bethania station rd; winston salem NC 27105
• Manufacturer (Section G): Wilson-Cook Medical Inc (Cook Endoscopy); 4900 bethania station rd; winston salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston salem, NC 27105 ; +1(336)744-0157
• MDR Report Key: 50882065
• Report Number: 1037905-2026-00576
• Device Sequence Number: 10755008
• Product Code: KNQ
• UDI-Device Identifier: 00827002213838
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G21383
• Device Catalogue Number: SGD-18-70
• Device Lot Number: W4987444
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/09/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2025
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown