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

Model Number WA53005A

Device Problem Break (1069)

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

Event Date 12/14/2022

Event Type  malfunction  

Manufacturer Narrative

The repair inspection confirmed the customer¿s reported problem, broken/shattered coverglass at the distal end of the scope causing a blurry/foggy image.The cause of the broken distal end coverglass is unknown, however, the investigation is still in progress.If additional information becomes available, this report will be supplemented accordingly.In general, the end-user is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.

Event Description

The olympus (omsi) field service engineer was informed by the nurse at the user facility that the customer high-definition quick lock autoclavable telescope was returned to the olympus repair center for a reported ¿vision is not ok¿.The customer reported procedure was found at reprocessing.During repair inspection, the distal end was found broken, broken/shattered coverglass at the distal end of the scope causing a blurry/foggy image.No death or injury and no impact to person or other was reported to olympus.This report is being submitted to capture the broken coverglass at the distal end found during repair inspection.

Manufacturer Narrative

This report was submitted to provide the investigation results for the reported device phenomenon.The device history records (dhr) was performed for the subject device without showing any non-conformities or deviations regarding the described issues.The investigation by the legal manufacturer determined that there is no design, manufacturing, material or processing related cause for the reported event.During the service inspection, the service department confirmed the distal end coverglass is broken.The exact cause of the broken coverglass cannot be conclusively determined.However, possible cause can be due to the use of excessive force by the customer.Olympus will continue to monitor the occurrence rate of the reported phenomenon related to the device.

• Brand Name: TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE
• Type of Device: HD AUTOCLAVABLE TELESCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 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: 16143635
• MDR Text Key: 308967681
• Report Number: 9610773-2023-00196
• Device Sequence Number: 1
• Product Code: EWY
• UDI-Device Identifier: 04042761052764
• UDI-Public: 04042761052764
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K912362
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/28/2023

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: 806333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/14/2022
• Initial Date FDA Received: 01/12/2023
• Supplement Dates Manufacturer Received: 03/17/2023
• Supplement Dates FDA Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2022
• 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