MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 110°, 4 MM; HYSTEROSCOPE (AND ACCESSORIES)

Model Number A22004A

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/30/2021

Event Type  Injury  

Event Description

A paralegal called to get the instruction for use for the oes pro resectoscope and reported to olympus that during a therapeutic left ureteroscopy and left stent placement, there was a severe tear in ureter.Attempts to obtain additional information were done, however, unsuccessful.

• Brand Name: TELESCOPE, 110°, 4 MM
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 17443673
• MDR Text Key: 320232405
• Report Number: 2429304-2023-00250
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761020879
• UDI-Public: 04042761020879
• 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: 07/12/2023,08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A22004A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/12/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other