MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 5.4 MM, 0°, AUTOCLAVABLE; LAPAROSCOPE

Model Number	WA50372B
Medical Device Problem Codes	Break (1069); Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A telescope (laparoscope) was returned to olympus for repair due to a damaged eyepiece.Image failure due to lens damage was reported.It is unknown when the reported issue was found.There was no harm or user injury reported due to the event.
Additional Manufacturer Narrative
The device was returned to olympus.The investigation is still in progress; therefore, the root cause of the reported defect cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.In general, the customer is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.Olympus will continue to monitor the field performance of this device.
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 customer's complaint was confirmed.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 could not be determined.It is likely the reported events, lens and eyepiece damage, occurred due to the use of excessive force.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 5.4 MM, 0°, AUTOCLAVABLE
• Common Device Name: 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: 16188479
• Report Number: 9610773-2023-00244
• Device Sequence Number: 6946791
• Product Code: GCJ
• UDI-Device Identifier: 04042761029599
• UDI-Public: 04042761029599
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K923982
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2023

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: WA50372B
• Device Catalogue Number: WA50372B
• Device Lot Number: 532802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2022
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 01/17/2023
• Supplement Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2007
• 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