MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OP-TELESCOPE, 30°, 4 MM CHANNEL; RIGID NEPHROSCOPE

Model Number	WA33036A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, by the customer, the rigid nephroscope had a blurry image.The event was found during reprocessing.There were no reports of patient harm.An onsite inspection report was provided by the customer that indicated the lenses were broken and there was darkening on the right side of the image.
Additional Manufacturer Narrative
The device was inspected/repaired by a 3rd party provider.The device was not returned for evaluation and could not be evaluated.Based on the results of the investigation, it is likely that the following led to the malfunction: bad light transmission due to broken fibers.The cause for all findings is very likely excessive force by the customer.A device history review revealed no issues that could have caused or contributed to the reported issue.This issue is addressed in the instructions for use (ifu): check image quality: a piece of writing held at approximately 10 mm from the objective lens must be clearly visible through the telescope.Damaged product: if the product is damaged or does not function properly, contact an olympus representative or an authorized service center.Olympus will continue to monitor the field performance of this device.Should additional relevant information become available, a supplemental report will be submitted.E1/full establishment name: (b)(6) hospital.

• Brand Name: OP-TELESCOPE, 30°, 4 MM CHANNEL
• Common Device Name: RIGID NEPHROSCOPE
• 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 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19190477
• Report Number: 9610773-2024-01108
• Device Sequence Number: 12677132
• Product Code: FGA
• UDI-Device Identifier: 04042761051866
• UDI-Public: 04042761051866
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K853486
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/26/2024

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: WA33036A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2017
• 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