MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. BALLOON 3 FOR ULTRASONIC ENDOSCOPE; ENDOSCOPIC ULTRASOUND SYSTEM, GASTROENTEROLOGY-UROLOGY

Model Number MAJ-249

Device Problem Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 02/25/2022

Event Type  malfunction  

Event Description

Post linear upper endoscopic ultrasound, the balloon was missing on distal end of scope.Manufacturer response for balloon, balloon 3 for ultrasonic endoscope (per site reporter).No response to date.

• Brand Name: BALLOON 3 FOR ULTRASONIC ENDOSCOPE
• Type of Device: ENDOSCOPIC ULTRASOUND SYSTEM, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 118 turnpike road; southborough MA 18034
• MDR Report Key: 13844681
• MDR Text Key: 287589946
• Report Number: 13844681
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-249
• Device Catalogue Number: MAJ-249
• 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: 03/11/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27740 DA
• Patient Sex: Female
• Patient Weight: 65 KG