MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 1.9 MM, 0°,210MM, AUTOCLAVABLE; RESECTOSCOPE

Model Number	A3764A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the device has not been returned to olympus for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus, the telescope, 1.9 mm, 0°,210mm, autoclavable had broken components.There were no reports of patient harm.
Event or Problem Description
The customer reported to olympus, the telescope, 1.9 mm, 0°,210mm, was smashed at the front of the optic.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information.Updated fields: b5.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to correct d9.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the event could not be determined although it can be presumed it was due to external mechanical force e.G.By fall, impact or shock most likely in combination with excessive/frequent use and/or unsuited/inappropriate handling.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 1.9 MM, 0°,210MM, AUTOCLAVABLE
• Common Device Name: RESECTOSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, deutschland 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, deutschland
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18167495
• Report Number: 9610773-2023-03344
• Device Sequence Number: 5709476
• Product Code: FJL
• UDI-Device Identifier: 04042761005722
• UDI-Public: 04042761005722
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K904940
• 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,Followup
• Report Date (Section B): 01/22/2024

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: A3764A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/05/2023
• Supplement Date Received by Manufacturer: 11/30/2023; 01/12/2024
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 12/02/2023; 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2017
• 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