MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE; MEDIASTINOSCOPE

Model Number WA53005A

Device Problems Break (1069); Crack (1135)

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

Event Date 03/03/2023

Event Type  malfunction  

Event Description

It was reported to olympus that a telescope was sent in for repair.During the inspection, there was damage to cover glass of outer cylinder as well as a crack.There was no patient injury or adverse event reported to olympus.

Manufacturer Narrative

The device was returned to olympus for evaluation and repair.The investigation is still in progress; therefore, the root cause of the reported defect cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.In general, the customer is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.Olympus will continue to monitor the field performance of this device.Additional pma/510(k): k923982/ k950076.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, device evaluation, and corrections to b3, b5, g2 (which were inadvertently left off the initial report), and h4.Foreign material inside the cover glass was also found during device evaluation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely that the event occurred due to user error, improper handling and wear and tear.Olympus will continue to monitor field performance for this device.

Event Description

The event occurred during reprocessing for a therapeutic procedure, which was completed.There was no delay.The device was inspected before use.

• Brand Name: TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE
• Type of Device: MEDIASTINOSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16736620
• MDR Text Key: 313257979
• Report Number: 9610773-2023-01029
• Device Sequence Number: 1
• Product Code: EWY
• UDI-Device Identifier: 04042761052764
• UDI-Public: 04042761052764
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K912362
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA53005A
• Device Catalogue Number: WA53005A
• Device Lot Number: 517387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2006
• 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