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

Model Number WA53005A

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

The referenced device was returned to the olympus repair center.The repair inspection confirmed the customer¿s reported issue, broken eyepiece.The inspection also observed dents on the rigid outer tube or at the ocular funnel and scratches on the surface of the outer tube.Olympus requested additional details regarding the reported device and event, but the information is pending.The investigation is in progress; therefore, the root cause cannot be determined at this time.However, 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

Olympus (omsc) was informed via repair request that the customer high-definition quick lock autoclavable telescope has a ¿broken eyepiece¿.The customer reported problem was found at an unspecified event.No death or injury and no impact to person or other was reported to olympus.

Manufacturer Narrative

This medwatch is being supplemented with additional information obtained and the manufacturer's final investigation results.During inspection, the service department found the following: eyepiece damaged; outer tube dent; strong scratches at outer tube or device.The reported failure mode/identified defects can be attributed to the user error, improper handling and application of excessive force.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: 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: 16128052
• MDR Text Key: 308748186
• Report Number: 9610773-2023-00141
• 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,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2023

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: 624852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2022
• Initial Date FDA Received: 01/09/2023
• Supplement Dates Manufacturer Received: 03/30/2023
• Supplement Dates FDA Received: 04/28/2023
• 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: Reuse
• Patient Sequence Number: 1