MAUDE Adverse Event Report: DIVERSATEK HEALTHCARE INC. MEDOVATIONS M-FLEX SILICONE BOUGIE 54FR; BOUGIE, ESOPHAGEAL, AND GASTROINTESTINAL, GASTRO-UROLOGY

Model Number 1206-54

Device Problems Leak/Splash (1354); Detachment of Device or Device Component (2907)

Patient Problem Chemical Exposure (2570)

Event Date 05/24/2021

Event Type  Injury  

Event Description

Endoscopy bougie being used in surgical case was being removed when the tip came off.The tip was retrieved, however tungsten powder from the bougie was noted in the pt's mouth.

• Brand Name: MEDOVATIONS M-FLEX SILICONE BOUGIE 54FR
• Type of Device: BOUGIE, ESOPHAGEAL, AND GASTROINTESTINAL, GASTRO-UROLOGY
• Manufacturer (Section D): DIVERSATEK HEALTHCARE INC. ; 102 east keefe ave; milwaukee WI 53212
• MDR Report Key: 11901004
• MDR Text Key: 253560716
• Report Number: MW5101618
• Device Sequence Number: 1
• Product Code: FAT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 1206-54
• Device Catalogue Number: 1206-54
• Device Lot Number: 22410Z
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 98