MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP DISPOSABLE DISTAL ATTACHMENT; GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number D-201-10704

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 02/22/2022

Event Type  malfunction  

Event Description

Disposal distal attachment device attached to egd scope per md.Device assessed appropriately prior to use, and placed at the end of egd scope.Distal attachment device seen in the patients stomach, dislodged from the scope.Distal attachment device was retrieved using a roth net.After assessing distal attachment, it was found that the attachment was cut in half.Fda safety report id# (b)(4).

• Brand Name: DISPOSABLE DISTAL ATTACHMENT
• Type of Device: GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP; tokyo 192-8 507; JA 192-8507
• MDR Report Key: 13634288
• MDR Text Key: 286461675
• Report Number: MW5107777
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/24/2022

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: D-201-10704
• Device Lot Number: 19K
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White