MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "OES ELITE", 4MM, 70, HD, AUTOCLAVABLE; RESECTOSCOPE

Model Number WA2T470A

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/27/2023

Event Type  malfunction  

Event Description

An fda medsun report was provided to olympus noting that a customer had reported his olympus bipolar resectoscope (unspecified model) broke off during use in a procedure.Additional details relating to the patient and the event have been requested, but no response has been received at this time.There was no patient harm or consequence reported as a result of this event.

Manufacturer Narrative

The device has not been returned for evaluation.If additional information becomes available prior to the conclusion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

This report is being submitted to capture additional information received from the initial reporter.That information is located in section d.Should further information be provided, another supplemental report will be submitted.

• Brand Name: TELESCOPE "OES ELITE", 4MM, 70, HD, AUTOCLAVABLE
• Type of Device: RESECTOSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17867328
• MDR Text Key: 324866707
• Report Number: 9610773-2023-02805
• Device Sequence Number: 1
• Product Code: FDC
• UDI-Device Identifier: 04042761077576
• UDI-Public: 04042761077576
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/01/2023

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: WA2T470A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/18/2023
• Initial Date FDA Received: 10/04/2023
• Supplement Dates Manufacturer Received: 10/27/2023
• Supplement Dates FDA Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1