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

Model Number WA53005A

Device Problem Break (1069)

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

Event Date 12/27/2022

Event Type  malfunction  

Event Description

It was reported to olympus that a telescope had a broken camera at the distal end.The reported issue was found during preparation for use of the device and the initial inspection.The facility finished the procedure with another device.There was no harm or user injury reported due to the event.

Manufacturer Narrative

The device was returned to olympus.During the device evaluation, the distal end light guide bundle was damaged and the image was normal.There was a bad or lost light transmission due to the broken fibers.Lastly, the internal lens were found displaced.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.

Manufacturer Narrative

This medwatch is being supplemented with additional information obtained and the manufacturer's final investigation results.During their inspection, the reported issue was not confirmed.During their inspection, the sbc found the following: 1.The distal end lg bundle was damaged (the image was normal).2.The internal lens was displaced (the image was normal).3.The broken distal end lens reported by the customer was not confirmed.The identified fault patterns are most likely attributable to the use of excessive force by the customer.A manufacturing and quality control review was performed for the affected serial number without showing any non-conformities or deviations regarding the described issues.

• Brand Name: TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE
• Type of Device: MEDIASTINOSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16237738
• MDR Text Key: 309030432
• Report Number: 9610773-2023-00334
• Device Sequence Number: 1
• Product Code: EWY
• UDI-Device Identifier: 04042761052764
• UDI-Public: 04042761052764
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K912362
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/21/2023

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: WA53005A
• Device Catalogue Number: WA53005A
• Device Lot Number: 803934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/27/2022
• Initial Date FDA Received: 01/24/2023
• Supplement Dates Manufacturer Received: 03/22/2023
• Supplement Dates FDA Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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