MAUDE Adverse Event Report: 40 FR LIGHTED BOUGIE, TRANSILLUMINATION ; RETRACTOR, FIBEROPTIC

Device Problems Overheating of Device (1437); Peeled/Delaminated (1454)

Patient Problem Injury (2348)

Event Date 04/02/2019

Event Type  Injury  

Event Description

Per op note from md: the standard 40 fr lighted bougie was used to help size the gastric pouch during surgery.This has been used for years for this purpose and for other foregut surgery such as sleeve, anti reflux, etc.I have never noted the bougie to be "hot".It is always connected to a fiber optic light source which is usually left on while the bougie is in use in the body.In this case, when i removed the bougie near the end of the case in preparation to perform intra op egd, the bougie was very warm to touch - specifically where the clear end of the bougie starts (there is metal visible inside the bougie at this location, estimated 1/2 inch length - this is where it was hot).There was a new fiber optic light source being used which i was unaware - luxtec mix.Egd showed the distal 10-15 cm of esophagus had thin layer of epithelium that was in places peeling away.One very small dark spot less than 5 mm diameter at 8 cm from z line.The underlaying esophageal tissue appeared perfused and viable.The pouch looked unremarkable.I asked one of the gi physicians to come and look, and he agreed it appeared to be an esophageal epithelial injury but he felt it was superficial and recommended carafate liquid, gi cocktail, observation, possible interval egd.I irrigated the esophagus.Did not place ng or g tube.Will continue antibiotics, npo for now, carafate and ppi rx, close observation, esophagram, possible repeat egd etc.I explained exactly what had occurred to the waiting family (mother and son) after surgery and later told the pt, but she is sleepy and will explain again tomorrow.Staff filed "safety zone report", i reported to operating room director and risk control, the devices are to be pulled off line for biomed evaluation.I informed my partners who also use this instrument.On literature review i could find no case reports of this occurring.Staff are concerned with design of device.At no time during use does device give any indication it is getting hot.Staff can continue to increase the light source settings to maximize visualization, without any indication that source is hot.There is no alarm, warning sound, or visual indication of the potential for a burn injury.There is no warning on machine that indicates this is of risk.We have also had one anecdotal report of an employee burn injury in handling of these.We have pulled them from use until we can determine what steps we can implement to prevent further injury to employees or pts.

• Brand Name: 40 FR LIGHTED BOUGIE, TRANSILLUMINATION
• Type of Device: RETRACTOR, FIBEROPTIC
• MDR Report Key: 8551261
• MDR Text Key: 143378421
• Report Number: MW5086185
• Device Sequence Number: 1
• Product Code: FDG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 37 YR
• Patient Weight: 158