MAUDE Adverse Event Report: CONMED CORPORATION CLEANGUIDE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number DIS150

Device Problem Material Deformation (2976)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) of Esophagus (2398)

Event Date 09/22/2022

Event Type  malfunction  

Event Description

Savary wire was used for esophageal dilation.The distal end of the wire kinked/ bent leaving a jagged edge ultimately injuring the distal esophageal mucosa and ge junction.The wire was removed from the patient and bagged with the original packaging.Per surgeon op note: "the ge junction was at 45cm from the incisors, and we noticed that the spring-loaded guidewire had kink at the junction where the wire meets a spring load component.This created a sharp edge and appeared to create some mucosal injury at the ge junction.We saw some mucosa that was lifted up in a small area." the surgeon did not think there was any full-thickness injury."there was a little bit of bleeding.The surgeon scoped carefully around this area and then entered the stomach, which had no injury.We performed a retroflexed view of the underside of the ge junction, which had no injury and no mucosal tear." manufacturer response for endoscopic guidewire, gastroenterology-urology, cleanguide (per site reporter).

• Brand Name: CLEANGUIDE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 16918374
• MDR Text Key: 315086805
• Report Number: 16918374
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/09/2023,12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIS150
• Device Catalogue Number: DIS150
• Device Lot Number: 202201054
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/09/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24090 DA
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Race: White