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
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 9610773-2023-02250
• Device Sequence Number: 17884206
• Product Code: EWY
• UDI-Device Identifier: 04042761077590
• UDI-Public: 04042761077590
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K971166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Supplement Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown