MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OLYMPUS BALLOON; GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number MAJ-1351

Device Problems Break (1069); Device Damaged by Another Device (2915)

Patient Problem Insufficient Information (4580)

Event Date 12/09/2022

Event Type  malfunction  

Event Description

Olympus ebus bronchoscope (bf-uc190f) damaged the aspiration needle and scope which led to the scope being inoperable to finish the procedure.1.Vantx obtained new bronchoscopes from olympus in october 2022.The new bronchoscopes were updated from the 180s to 190s.2.Three of the new 190 bronchoscopes were noted to be damaging other products and or having damages scope fibers after the aspiration needle was passed, specifically listed below: a.Scope fibers breaking b.Aspiration needle damage (model no.Na-201sx-4021; manufactured by olympus) c.Aspiration needle sheath damaged d.Balloon (model no.Maj-1351; manufactured by olympus) used for ultrasound does not properly fit (too large) the new 190 scopes.Makes it a risk for the balloon to be come off the scope while it is being used.3.The scopes were sent multiple times to a third party for repair.4.Olympus took one scope as a control to repair it themselves as they thought the problem may have been related to the third-party repairs.Olympus returned the repaired scope after 6 weeks after.It had to be sent back to olympus for repair as it was noted to be damaging equipment again.5.Vantx does have a loner 180 scope that has not caused any damage other products or the scope itself.6.The scopes have been sent multiple times for repair (x1 repair by manufacturer) and continue to damage other products or have damaged themselves posing a risk for the patient and delaying care.Reference reports: mw5117129, mw5117131.

• Brand Name: OLYMPUS BALLOON
• Type of Device: GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.
• MDR Report Key: 16843320
• MDR Text Key: 314491047
• Report Number: MW5117130
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-1351
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS EBUS BRONCHOSCOPE (BF-UC190F).; OLYMPUS SINGLE USE ASPIRATION NEEDLE (NA-201SX-4021).
• Patient Age: 79 YR
• Patient Sex: Male