MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 10 MM, 45°, 460 MM, QUICK LOCK, AUTOCLAVABLE; RIGID OPTICAL LAPAROSCOPE

Model Number	WA52006A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During inspection and testing, the optical system had sunk down.The reported issue (foggy image) was confirmed due to debris on the optical system.In addition, there were scratches on the outer tube.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
The customer reported the image from the subject device was foggy when entering the patient during a laparoscopic sleeve procedure.The procedure was completed using another similar device and there was no effect on the patient due to the event.The subject device was sent to an olympus service center for evaluation.During inspection and testing, service found the optical system had sunk down.This report is being submitted for the malfunction found during evaluation (sunk down optical system).
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 definitive root cause of the broken components could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 10 MM, 45°, 460 MM, QUICK LOCK, AUTOCLAVABLE
• Common Device Name: RIGID OPTICAL LAPAROSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; 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: 15987284
• Report Number: 9610773-2022-00658
• Device Sequence Number: 6209270
• Product Code: GCJ
• UDI-Device Identifier: 04042761052726
• UDI-Public: 04042761052726
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2023

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: WA52006A
• Device Catalogue Number: WA52006A
• Device Lot Number: 652755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2022
• Supplement Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2013
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS 4K CAMERA
• Patient Sex: Unknown