MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "ULTRA", 4 MM, 70°; AUTOCLAVABLE TELESCOPE

Model Number	WA4KS470
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Olympus (osh) field service engineer was informed by the customer that the olympus loaner ultra autoclavable telescope has an image problem, there is a shadow in the lower right corner of the surrounding area of the image.The reported problem was found during maintenance.No death, injury or harm was reported to olympus.The referenced telescope was returned to the olympus repair center and the inspection identified a cracked lens inside the optical system.This report is being submitted to capture cracked lens.
Additional Manufacturer Narrative
During the repair inspection, no damage to the external areas of the telescope and no image abnormality was observed.The concerned device has not been repaired in the past year.The investigation is in progress.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.
Additional Manufacturer Narrative
The customer reported the following: ¿image central fog.¿ and ¿there was a shadow in the lower right corner of the surrounding area of the image.¿ during their inspection, the service business center (sbc) found the following: lens breakage a review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 3 years since the subject device was manufactured.Based on the results of the investigation, it is likely that the following led to the malfunction: the identified fault pattern is most likely attributable the use of excessive force by the customer.Olympus will continue to monitor the field performance of this device.

• Brand Name: TELESCOPE "ULTRA", 4 MM, 70°
• Common Device Name: 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: 16099262
• Report Number: 9610773-2023-00082
• Device Sequence Number: 17818686
• Product Code: EOB
• UDI-Device Identifier: 04042761083089
• UDI-Public: 04042761083089
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K153009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2023

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
• Operator of Device: Health Professional
• Device Model Number: WA4KS470
• Device Catalogue Number: WA4KS470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2022
• Supplement Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 04/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown