MAUDE Adverse Event Report: MEDOVATIONS INNERVISION / DIVERSATEK HEALTHCARE, INC. MEDOVATIONS INNERVISION DETACHABLE TIPS 50F; 50F BOUGIE TIP / DETACHABLE BOUGIE TIP

Model Number 1465-50

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/16/2018

Event Type  Injury  

Event Description

A 50f bougie tip became dislodged from the illumination cord in the patient¿s esophagus.

• Brand Name: MEDOVATIONS INNERVISION DETACHABLE TIPS 50F
• Type of Device: 50F BOUGIE TIP / DETACHABLE BOUGIE TIP
• Manufacturer (Section D): MEDOVATIONS INNERVISION / DIVERSATEK HEALTHCARE, INC. ; milwaukee WI 53212
• MDR Report Key: 8253670
• MDR Text Key: 133700016
• Report Number: MW5083164
• Device Sequence Number: 1
• Product Code: FAT
• UDI-Device Identifier: 00816734021293
• UDI-Public: (01)00816734021293
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2021
• Device Model Number: 1465-50
• Device Lot Number: 221575
• 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: 68 YR
• Patient Weight: 76