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

Model Number	G57281
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Laceration(s) of Esophagus (2398)
Date of Event	01/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report.
Event or Problem Description
During an endoscopic procedure, the physician used a cook savary-gilliard wire guide.While placing the esophageal stent, the wire was in place.When the physician went to place the stent over the wire, there was visible resistance.Physician was having difficulty pushing the stent over the wire in the patients mouth.When the physician pulled the stent out of the wire, the wire was bent in three (3) places.When the wire and stent were pulled out, the endoscope was put back down and the physician could see bleeding that was not noticed prior.Later, the physician noticed a tear in the throat after attempting to place the stent.Physician stated forcing the stent was the reason for the tear.It is currently unknown if the bleeding [initially seen after the wire guide was found bent] is related to the tear.A section of the device did not remain inside the patient¿s body.The patient required sutures for a tear in the throat experiencing bleeding.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
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 was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: the information received indicated that the device was used with an esophageal stent.The esophageal stent is incompatible with the savary-gilliard wire guide and against its intended use.The intended use in the instructions for use states that: "this device is used to introduce the savary-gilliard dilator." this is the most likely cause for the reported observation.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: 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.Based on the information provided for abnormal use of the device, 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 or Problem Description
During an endoscopic procedure, the physician used a cook savary-gilliard wire guide.While placing the esophageal stent, the wire was in place.When the physician went to place the stent over the wire, there was visible resistance.Physician was having difficulty pushing the stent over the wire in the patients mouth.When the physician pulled the stent out of the wire, the wire was bent in three (3) places.When the wire and stent were pulled out, the endoscope was put back down and the physician could see bleeding that was not noticed prior.Later, the physician noticed a tear in the throat after attempting to place the stent.Physician stated forcing the stent was the reason for the tear.It is currently unknown if the bleeding [initially seen after the wire guide was found bent] is related to the tear.Additional information was provided by customer on (b)(6) 2020.The user facility is unable to pinpoint what contributed to the tear.A section of the device did not remain inside the patient¿s body.The patient required sutures for a tear in the throat experiencing bleeding.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: SAVARY-GILLIARD WIRE GUIDE
• Common Device Name: KNQ, DILATOR, ESOPHAGEAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 9656079
• Report Number: 1037905-2020-00054
• Device Sequence Number: 11232084
• Product Code: KNQ
• UDI-Device Identifier: 00827002572812
• UDI-Public: (01)00827002572812(17)221126(10)W4291239
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/26/2022
• Device Model Number: G57281
• Device Catalogue Number: SGW-250-SD-D
• Device Lot Number: W4291239
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 01/31/2020
• Supplement Report FDA Received Date: 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENDOSCOPE, UNKNOWN MAKE OR MODEL
• Outcome Attributed to Adverse Event: Required Intervention