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

Model Number WA53005A

Device Problem Break (1069)

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

Event Date 10/26/2023

Event Type  malfunction  

Manufacturer Narrative

This combined initial/supplemental report is being submitted to provide the initially reported event as well as the results of the manufacturer¿s investigation.A device evaluation, an attempted review of the device history record (dhr), as well as a historical trending analysis were conducted during this investigation.An olympus field service engineer (fse) was dispatched to the user¿s facility to examine the device and confirmed that the eyepiece was broken.The review of the dhr was not possible as a proper serial number for the subject device was not provided.Based on the results of the investigation, and the condition of the subject device, it is believed that excessive force caused the reported failure mode.Olympus will continue to monitor the field performance of this device.

Event Description

The customer initially reported that his olympus 10mm autoclavable telescope was found damaged during device reprocessing.There was no patient involvement during this event.An olympus field service engineer (fse) was dispatched to the user¿s facility to examine the device and confirmed that the eyepiece was broken.This report is being submitted to capture the confirmed broken eyepiece noted during the fse¿s visit.

• Brand Name: TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE
• Type of Device: TELESCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18140188
• MDR Text Key: 328169187
• Report Number: 9610773-2023-03298
• Device Sequence Number: 1
• Product Code: EWY
• UDI-Device Identifier: 04042761052764
• UDI-Public: 04042761052764
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K912362
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA53005A
• Device Lot Number: 554810
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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