MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OLYMPUS DISTAL CAP; ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM

Model Number MAJ-2315

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 12/23/2021

Event Type  Injury  

Event Description

Doctor inserted endo scope in patient.There was some confusion weather the cap was in place prior to the procedure when the scope was removed without the distal cap attached.Later in post-op the patient spit out a distal cap.Fda safety report id# (b)(4).

• Brand Name: OLYMPUS DISTAL CAP
• Type of Device: ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.
• MDR Report Key: 13206033
• MDR Text Key: 283611044
• Report Number: MW5106531
• Device Sequence Number: 1
• Product Code: NWB
• 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: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MAJ-2315
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 99 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White