MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "IR", 5.4 MM, 30°; RIGID OPTICAL LAPAROSCOPE

Model Number	WAIR530A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
An olympus employee reported on behalf of a customer that there was a crack in the telescope.The event occurred within the operating room (or) during preparation for use.There was no report of patient harm.
Additional Manufacturer Narrative
The subject device was returned to olympus for evaluation.During inspection and testing, the allegation was confirmed due to broken optical lenses.The device evaluation found; the outer tube was bent.The object window had dents on the edges.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's 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 2 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, a definitive root cause of the broken optical lenses could not be identified.However, it¿s likely the cause is related to excessive force applied by the customer.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE "IR", 5.4 MM, 30°
• Common Device Name: RIGID OPTICAL LAPAROSCOPE
• 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: 18409024
• Report Number: 9610773-2023-03787
• Device Sequence Number: 2748107
• Product Code: GCJ
• UDI-Device Identifier: 04042761086189
• UDI-Public: 04042761086189
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2024

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: WAIR530A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2023
• Supplement Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2022
• 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