MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 30°, WIDEANGLE, 4 MM; HYSTEROSCOPE, GYNECOLOGY

Model Number	A22005A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported the hysteroscope's light post was stuck inside the light lead.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was returned to olympus for inspection, and the reportable malfunction was confirmed.New information was added to the following fields: d8, d9, h3, and h6.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 lens inside the optical system was damaged.It is likely the defect was caused by the effect of an excessive mechanical force caused by an impact or fall.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 30°, WIDEANGLE, 4 MM
• Common Device Name: HYSTEROSCOPE, GYNECOLOGY
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19213422
• Report Number: 9610773-2024-01139
• Device Sequence Number: 18177349
• Product Code: HIH
• UDI-Device Identifier: 04042761020886
• UDI-Public: 04042761020886
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K897003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2024

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: A22005A
• Device Lot Number: 645062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2013
• 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