MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH MEDIASTINOSCOPE, 35°, 160 MM WORKING LENGTH, AUTOCLAVABLE; OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECE

Model Number WA52050A

Device Problem Break (1069)

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

Event Date 07/18/2023

Event Type  malfunction  

Event Description

A user facility reported to olympus a piece of metal broke off the unit on mediastinoscope, 35°, 160 mm working length, autoclavable.The malfunction was found during reprocessing.There were no reports of patient or user harm associated with this event.

Manufacturer Narrative

The device was returned to olympus for evaluation.During the evaluation, the customer's original reported issue of a broken off piece of metal was confirmed on the outer tube.They also noted debris in the optical system and minor dents on the eye piece funnel.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation, or if any additional information is provided by the user facility.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Additional information added to field h6 and h3.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 8 years since the subject device was manufactured.Based on the results of the investigation, the reported malfunction was confirmed.It was presumed that these issues were caused by improper handling of the affected device by the user, more precisely, by an external force, such as a fall or a rough handling of the device during use or reprocessing.Olympus will continue to monitor field performance for this device.

• Brand Name: MEDIASTINOSCOPE, 35°, 160 MM WORKING LENGTH, AUTOCLAVABLE
• Type of Device: OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECE
• 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: 17552177
• MDR Text Key: 321740954
• Report Number: 9610773-2023-02250
• Device Sequence Number: 1
• Product Code: EWY
• UDI-Device Identifier: 04042761077590
• UDI-Public: 04042761077590
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

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: WA52050A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/19/2023
• Initial Date FDA Received: 08/15/2023
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2016
• 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