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

Model Number 1465-50

Device Problem Use of Device Problem (1670)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 04/19/2019

Event Type  Injury  

Manufacturer Narrative

During a routine manufacturer review of the online fda maude database, manufacturer discovered report mw5086352.This report was never made to the manufacturer.The report did not contain any information identifying the customer/user facility, so the manufacturer was not able to perform a complete investigation.The report states: "retained bougie tip requiring surgical intervention to remove due to using against mfr's recommendations".The device labeling indicates that the tip can come detached from the cable if the tip is bent at a significant angle within the patient.The device history record of the production lot was reviewed and no issues were recorded.The manufacturer also reviewed complaint trending reports.No other complaints were received on this production lot.Based on a review of trending reports and the information available, the device is not believed to have caused or contributed to the event.Diversatek healthcare 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

During a routine review of the fda maude database, manufacturer discovered event reported on device that was not reported to manufacturer.Per mw5086352, "retained bougie tip requiring surgical intervention to remove due to using against mfr's recommendations".This is the only known information.

• 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: 8932030
• MDR Text Key: 160248390
• Report Number: 2183446-2019-00001
• Device Sequence Number: 1
• Product Code: FDG
• Combination Product (y/n): N
• PMA/PMN Number: K964561
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 08/19/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 09/12/2021
• Device Model Number: 1465-50
• Device Catalogue Number: 1465-50
• Device Lot Number: 222549
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/02/2019
• Initial Date FDA Received: 08/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2018
• 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