MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 1.9 MM, 30°, 115 MM, AUTOCLAVABLE; AUTOCLAVABLE TELESCOPE

Model Number	A7507A
Medical Device Problem Codes	Mechanical Problem (1384); Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned to the olympus, and the inspection has reproduced the customer's reported issue.Following are the device evaluation findings: deformation of outer tube or working channel and foreign particles in optical system.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported to olympus, that the olympus autoclavable telescope, the lens and the image are blurred and the connection with the camera head has come loose.No death, injury or harm to patient or other has been reported to olympus.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see updates to h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 5 years since the subject device was manufactured.Based on the results of the investigation, i¿s likely the damaged components were caused by user error, improper handling, and/or application of excessive force.The final root cause of this event was unable to be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 1.9 MM, 30°, 115 MM, AUTOCLAVABLE
• Common Device Name: AUTOCLAVABLE TELESCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 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: 16396130
• Report Number: 9610773-2023-00530
• Device Sequence Number: 12097503
• Product Code: HRX
• UDI-Device Identifier: 04042761010986
• UDI-Public: 04042761010986
• 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,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2023

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: A7507A
• Device Catalogue Number: A7507A
• Device Lot Number: 749691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2023
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 02/17/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2017
• 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