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 Type  malfunction  

Event Description

Olympus (omsc) was informed that the customer high-definition, quick lock, autoclavable telescope was returned to the olympus repair center for a reported ¿damaged eyepiece¿.The reported problem was found during an unspecified event.No death, injury or harm was reported.

Manufacturer Narrative

The subject telescope was returned to the olympus repair center.The repair inspection confirmed the customer reported issue, the eyepiece is damaged.The cause of the damaged eyepiece is unknown.Additional information was requested from the customer regarding the details of the event, but no information has been received to date.However, the investigation is ongoing.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.

Manufacturer Narrative

This supplemental report was submitted to provide the results of the legal manufacturer¿s investigation.The device history records (dhr) was reviewed and it was confirmed that the device met standards at the time of shipment.The manufacturing and quality control review was performed without showing any non-conformities or deviations regarding the described issue.The investigation by the legal manufacturer determined that there is no design, manufacturing, material or processing related cause for the reported event.The exact cause of the broken eyepiece cannot be conclusively determined.However, based on the repair evaluation, the cause of the customer¿s reported event could potentially be due to user error, improper handling and application of excessive force.Olympus will continue to monitor complaints for this 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: 16019334
• MDR Text Key: 308112934
• Report Number: 9610773-2022-00704
• Device Sequence Number: 1
• Product Code: EWY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K950076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: WA53005A
• Device Catalogue Number: WA53005A
• Device Lot Number: 624862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1