MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 1,9 MM, 0°, 65 MM, AUTOCLAVABLE; RIGID SCOPE

Model Number	A7504A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the tip of the scope was chipped.There were no reports of harm.
Additional Manufacturer Narrative
The subject device was returned to an olympus repair center for evaluation and the customer¿s reported issue was confirmed.The device evaluation found an outer tube dent (tip chipped).The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on 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.It has been over 8 years since the subject device was manufactured.The investigation determined that the issue could have been caused by stress caused by repeated use, external factors or handling of device; however, the root cause was not definitely established.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 1,9 MM, 0°, 65 MM, AUTOCLAVABLE
• Common Device Name: RIGID SCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 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: 18096951
• Report Number: 9610773-2023-03217
• Device Sequence Number: 6061277
• Product Code: HRX
• UDI-Device Identifier: 04042761010955
• UDI-Public: 04042761010955
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K951354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2024

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: A7504A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2023
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2005
• 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