MAUDE Adverse Event Report: MEDOVATIONS / DIVERSATEK HEALTHCARE INC. DISPOSABLE LIGHTED BOUGIE TIP 40; BOUGIE, ESOPHAGEAL, AND GASTROINTESTINAL, GASTRO-UROLOGY

Device Problems Material Separation (1562); Device Sensing Problem (2917)

Patient Problems Nausea (1970); Pain (1994); Vomiting (2144)

Event Date 01/07/2020

Event Type  Injury  

Event Description

The tip of a lighted bougie was retained in a pt's esophagus following removal of a lighted bougie.The lighted bougie was used during a laparoscopic nissen procedure and the separation of the tip was not recognized.On the morning following surgery, pt complained of nausea, vomiting and a pain score of 12/10.Foreign object identified in the posterior oral pharynx and removed at bedside with forceps.Foreign object identified as the disposable tip of a lighted bougie.Permanent harm was not assessed.Fda safety report id# (b)(4).

• Brand Name: DISPOSABLE LIGHTED BOUGIE TIP 40
• Type of Device: BOUGIE, ESOPHAGEAL, AND GASTROINTESTINAL, GASTRO-UROLOGY
• Manufacturer (Section D): MEDOVATIONS / DIVERSATEK HEALTHCARE INC. ; milwaukee WI 43212
• MDR Report Key: 9810761
• MDR Text Key: 183133501
• Report Number: MW5093628
• Device Sequence Number: 1
• Product Code: FAT
• Combination Product (y/n): N
• 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: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 61 YR
• Patient Weight: 61