MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC SAVARY-GILLIARD WIRE GUIDE; DILATOR, ESOPHAGEAL

Model Number	G57280
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in an open pouch from the lot number provided in the report.The label matches the product returned.Our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with a kink in the coil spring.The kink in the wire was at 199.6cm on the distal end.The rest of the wire guide was not damaged.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 investigation confirmed a bend near the distal end of the device.A definitive cause for this observation could not be determined because the actual product handling conditions could not be duplicated in the laboratory setting.This limits our ability to conclusively determine a cause.Prior to distribution, all savary-gilliard wire guides are subjected to a visual inspection and functional testing 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.This observation was made prior to use.A review of the complaint history was conducted.Based on this review, the likelihood of this type of report is rare.Quality assurance will continue to monitor for complaint trends.
Event or Problem Description
In preparation for an endoscopic procedure, the physician used a cook savary-gilliard wire guide.It was reported [that] when user opened the package, they noticed that the tip of the wire was significantly kinked.The procedure was successfully completed with another device of the same type.This occurred prior to patient contact; there was no impact to the patient.In addition, the patient sustained no clinical consequence and there were no adverse effects to the patient.

• Brand Name: SAVARY-GILLIARD WIRE GUIDE
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section G): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 23993951
• Report Number: 1037905-2026-00010
• Device Sequence Number: 10509665
• Product Code: KNQ
• UDI-Device Identifier: 00827002572805
• UDI-Public: (01)00827002572805(17)280707(10)W4953565
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/07/2026

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: G57280
• Device Catalogue Number: SGW-200-SD-D
• Device Lot Number: W4953565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2025
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown