MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. OLYMPUS COLONOSCOPE

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Unspecified Mental, Emotional or Behavioural Problem (4430); Unspecified Tissue Injury (4559)

Event Date 02/16/2022

Event Type  Injury  

Event Description

Olympus medical systems corp.(omsc) received a summons.The summons detailed that the plaintiff underwent a routine screening colonoscopy using an olympus colonoscope.The plaintiff reportedly sustained unspecified permanent injuries to the colon and required emergency surgery, hospitalization, and medical care.Consequently, the plaintiff suffered severe and excruciating pain, and distressing mental anguish.In addition, the plaintiff has been unable to engage in their employment for a time subsequent to said incident and will reportedly be unable to work for an indefinite period of time.The plaintiff further alleged that the defendants malpractice and the negligently manufactured colonoscope contributed to the injuries.E1 - the initial reporter's title is attorney.

• Brand Name: OLYMPUS COLONOSCOPE
• Type of Device: COLONOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• MDR Report Key: 17575703
• MDR Text Key: 321523645
• Report Number: 2429304-2023-00260
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/28/2023,08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/28/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability