MAUDE Adverse Event Report: HOYA CORPORATION PENTAX DIVISION PENTAX VIDEO GASTROSCOPE; GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number EG-1690K

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2023

Event Type  malfunction  

Event Description

Patient history includes congenital laryngomalacia, s/p supraglottoplasty, bilateral inferior turbinate reduction and bmt placement.Surgery on [date redacted]--endoscope breakdown - endoscope used during procedure failed to blow air and allow insufflation of the upper gi tract precluding completion of the procedure safely.The procedure was therefore suspended, and followed by multiple troubleshooting steps that failed until the scope was changed (larger scope available on site).Therefore, team had to request equivalent 17 series scope, which, after inherent delay, was used to complete the endoscopy uneventfully.Patient had increased duration of procedure over routine 5 mins.There are several events, and this issue has been experienced by several physicians.In all instances, the procedure (usually but not exclusively a colonoscopy) starts uneventfully.During the procedure, more likely if prolonged / poor cleanout, the endoscope suctions the luminal contents without the suction button being depressed.Once this starts, it tends to get worse.In some cases, changing the valve to a non-disposable valve improved / resolved the issue.This leads to poor and non-sustained insufflation of the intestinal lumen, resulting in poor visualization of the lumen.This impacts: (1) the ability to identify abnormalities, therefore the possibility of missing pathology, (2) recognizing landmarks necessary to complete the procedure, and (3) prolonging the procedure or rendering it harder to complete.Eventually, and in the more serious events, suction overcame insufflation resulting in suction into the mucosa.This leads to extreme difficulty completing the procedure, mucosal injury through creation of 'suction polyps', and mucosal trauma as was documented.The inability to maintain luminal insufflation also gives rise to the suspicion of perforation, which then has ramifications including non-completed procedure.

• Brand Name: PENTAX VIDEO GASTROSCOPE
• Type of Device: GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): HOYA CORPORATION PENTAX DIVISION; 3 paragon drive; montvale NJ 07645
• MDR Report Key: 16991741
• MDR Text Key: 315841000
• Report Number: 16991741
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG-1690K
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/15/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/24/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 270 DA
• Patient Sex: Male
• Patient Weight: 7 KG