MAUDE Adverse Event Report: DIVERSATEK HEALTHCARE INNERVISION TRANSILLUMINATION SYSTEM; LIGHTED BOUGIE, PRODUCT CODE: FDG

Model Number 1465-40

Device Problem Use of Device Problem (1670)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/07/2020

Event Type  Injury  

Manufacturer Narrative

The customer reported the detached tip was located in the patient's esophagus and retrieved bedside after completion of a nissen fundoplication.The device labeling indicates that the tip can come detached from the cable if the tip is bent at a significant angle during extubation.The device history record of the production lot was reviewed and no issues were recorded.The returned bougie tip was examined and no manufacturing defects were found.The manufacturer also reviewed complaint trending reports.No other complaints have been received for this lot number.Additionally, no other complaints have been received for this size/model of device.Based on a review of the 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 future action will be taken.

Event Description

Per sus voluntary event repot / medwatch report mw5093628) from (b)(6): the tip of the lighted bougie was retained in a pt's esophagus following removal of a lighted bougie.The lighted bougie was used during a laparoscopic nissen procedure and the separation of the tip was not recognized.On the morning following surgery, pt complained of nausea, vomiting and a pain score of 12/10.Foreign object identified in the posterior oral pharynx and removed at bedside with forceps.Foregin object identified as the disposable tip of a lighted bougie.Permanent harm was not assessed.Fda safety report id# (b)(4).

• Brand Name: INNERVISION TRANSILLUMINATION SYSTEM
• Type of Device: LIGHTED BOUGIE, PRODUCT CODE: FDG
• Manufacturer (Section D): DIVERSATEK HEALTHCARE; 102 e keefe ave; milwaukee, wi
• Manufacturer (Section G): DIVERSATEK HEALTHCARE; 102 e keefe ave; milwaukee, wi
• Manufacturer Contact: laura boll ; 102 e keefe ave; milwaukee, wi ; 2657620480
• MDR Report Key: 9972231
• MDR Text Key: 191838214
• Report Number: 2183446-2020-00001
• Device Sequence Number: 1
• Product Code: FDG
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2021
• Device Model Number: 1465-40
• Device Catalogue Number: 1465-40
• Device Lot Number: 222548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2018
• 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
• Patient Age: 61 YR
• Patient Weight: 61