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

Model Number 1465-50

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) of Esophagus (2398)

Event Date 05/16/2018

Event Type  Injury  

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 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
• Type of Device: LIGHTED BOUGIE
• Manufacturer (Section D): DIVERSATEK HEALTHCARE; 102 e keefe ave; milwaukee WI 53212
• Manufacturer (Section G): DIVERSATEK HEALTHCARE; 102 e keefe ave; milwaukee WI 53212
• Manufacturer Contact: laura boll ; 102 e keefe ave; milwaukee, WI 53212 ; 4142657620
• MDR Report Key: 7820278
• MDR Text Key: 118346180
• Report Number: 2183446-2018-00001
• Device Sequence Number: 1
• Product Code: FDG
• UDI-Device Identifier: 00816734021293
• UDI-Public: (01)00816734021293(10)221575(17)210327
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964561
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/05/2018,08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/05/2018
• Distributor Facility Aware Date: 05/16/2018
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2018
• Date Manufacturer Received: 07/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention