MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "IR", 10 MM, 0°; RIGID SCOPE

Model Number	WAIR100A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's allegation was confirmed due to the tip cover glass being damaged.In addition to the reportable malfunction documented in b5, the additional device evaluation findings are as follows: the gold plating on the outer tube was peeling, there was foreign material inside the cover glass, there was an image failure due to cover glass adhesions, and there were image defects due to foreign material adhering to the internal lens.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus, the olympus rigid scope had a damaged tip.The issue was associated with a therapeutic procedure that was completed with a similar device.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was found: the tip cover glass was damaged.There was no report of patient injury or medical intervention associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during the device evaluation.
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.Based on the results of the investigation, the root cause of the event could not be determined although it can be presumed that it was due to wear and tear as well as excessive force.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE "IR", 10 MM, 0°
• 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: 18307485
• Report Number: 9610773-2023-03595
• Device Sequence Number: 17793259
• Product Code: GCJ
• UDI-Device Identifier: 04042761083621
• UDI-Public: 04042761083621
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200542
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2024

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: WAIR100A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2020
• 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