MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 3 MM, 12°, AUTOCLAVABLE; RIGID ENDOSCOPE TELESCOPE, HYSTEROSCOPES

Model Number	A4673A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the lens on the tip end of the rigid endoscope telescope was broken.It is unknown when the issue occurred.There were no reports of patient harm.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's 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 inspection, and the customer's complaint/reportable malfunction was confirmed.Based on the results of the investigation, a definitive root cause could not be determined.However, the reported error descriptions were most likely due to the effect of a large mechanical force from a shock or fall.Additionally, the worn distal end was likely due to wear and tear, which corresponds to the age of the item, as well as frequent use and a lack of maintenance, poor reconditioning such as cleaning, disinfection, and sterilization (cds).Olympus will continue to monitor the field performance for this device.

• Brand Name: TELESCOPE, 3 MM, 12°, AUTOCLAVABLE
• Common Device Name: RIGID ENDOSCOPE TELESCOPE, HYSTEROSCOPES
• 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: 19457598
• Report Number: 9610773-2024-01369
• Device Sequence Number: 7972632
• Product Code: GCP
• UDI-Device Identifier: 04042761006354
• UDI-Public: 04042761006354
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K904939
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2024

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: A4673A
• Device Lot Number: 903577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2024
• 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: 05/29/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/1999
• 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