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

Model Number MAJ-2315

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/18/2022

Event Type  Injury  

Event Description

Patient had an ercp completed.Upon completion the scope was removed and placed on cart.Staff noticed that the scope did not have the distal tip on.Md went back in with a gastroscope to try and find the tip and was not able to locate the tip in the patient.Fluoroscopy and ct completed but due to cap being plastic unable to be visualized.Fda safety report id # (b)(4).

• Brand Name: OLYMPUS SINGLE USE DISTAL COVER
• Type of Device: ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.
• MDR Report Key: 14207159
• MDR Text Key: 290164764
• Report Number: MW5109357
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 14953170403016
• UDI-Public: (01)14953170403016(17)240930(10)
• 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: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-2315
• Device Lot Number: H1X14
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Ethnicity: Hispanic