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

Model Number	1465-50
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/16/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
A 50f bougie tip became dislodged from the illumination cord in the pt's esophagus.

• Brand Name: MEDOVATIONS INNERVISION DETACHABLE BOUGIE TIPS 50F
• Common Device Name: RETRACTOR, FIBEROPTIC
• Manufacturer (Section D): MEDOVATIONS INC. / DIVERSATEK HEALTHCARE INC. ; milwaukee WI 53212
• MDR Report Key: 7673391
• Report Number: MW5078295
• Device Sequence Number: 19044503
• Product Code: FDG
• UDI-Device Identifier: 00816734021293
• UDI-Public: (01)00816734021293
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/27/2021
• Device Model Number: 1465-50
• Device Lot Number: 221575
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 76