MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "OES ELITE", 4 MM, 30 °, WIDE-ANGLE, HD, AUTOCLAVABLE; RIGID ENDOSCOPE TELESCOPE

Model Number	WA2T43WA
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1- (b)(6) hospital.The device was returned and the evaluation found that no additional reportable malfunctions.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the rigid endoscope telescope's light guide connection port was damaged.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was returned to olympus for evaluation and the customer's reportable malfunction was confirmed.The light guide post was found loose and detached from the base.Based on the results of the investigation, it is likely that the damage to the device was caused by improper handling and application of excessive force like fall, shock or similar stress.However, a definitive root cause could not be determined.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The event was observed after completion of a transcervical resection (tcr) procedure.There was no patient involvement.

• Brand Name: TELESCOPE "OES ELITE", 4 MM, 30 °, WIDE-ANGLE, HD, AUTOCLAVABLE
• Common Device Name: RIGID ENDOSCOPE TELESCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg/de/germany 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg/de/germany
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18921071
• Report Number: 9610773-2024-00743
• Device Sequence Number: 18021208
• Product Code: FGC
• UDI-Device Identifier: 04042761077569
• UDI-Public: 04042761077569
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151191
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2024

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: WA2T43WA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2024
• 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: 03/04/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2017
• 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