MAUDE Adverse Event Report: DIVERSATEK HEALTHCARE INNERVISION TRANSILLUMINATION SYSTEM; LIGHTED BOUGIE

Model Number	1465-50
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Laceration(s) of Esophagus (2398)
Date of Event	05/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported a tear of the esophagus after the disposable tip detached from the device.The tear was repaired through endoscopic intervention.The customer believes the tip folded back on itself during passage through the esophagus.The device labeling indicates that the tip can come detached if the tip is bent at a significant angle within the patient.Disposable tips from the same manufacturing lot were examined and all specifications were within tolerances.Additionally, the device history record of the manufacturing lot was reviewed and no issues were recorded.The manufacturer also reviewed complaint trending reports.No similar issues have been reported in any complaint trends.Therefore, the manufacturer believes this to be an isolated incident.The device is not believed to have caused or contributed to the event.Diversatek has determined that there are no new safety or efficacy issues as a result of this event and therefore, no further action will be taken.
Event or Problem Description
Customer reported on mw5078295 the 50fr bougie tip became dislodged from the illumination cord in the patient's esophagus.

• Brand Name: INNERVISION TRANSILLUMINATION SYSTEM
• Common Device Name: LIGHTED BOUGIE
• Manufacturer (Section D): DIVERSATEK HEALTHCARE; 102 e keefe ave; milwaukee WI 53212
• MDR Report Key: 7820278
• Report Number: 2183446-2018-00001
• Device Sequence Number: 16755801
• Product Code: FDG
• UDI-Device Identifier: 00816734021293
• UDI-Public: (01)00816734021293(10)221575(17)210327
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K964561
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/02/2018
• Report Date (Section F): 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/27/2021
• Device Model Number: 1465-50
• Device Catalogue Number: 165-50
• Device Lot Number: 221575
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/16/2018
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 08/27/2018
• 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
• Date Report Sent to FDA: 07/05/2018