MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 4 MM, 12°, LONG; RIGID SCOPE

Model Number	WA20021A
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a therapeutic transurethral resection of prostate procedure, the telescope on its first use did not fail during the procedure, but it gave a view of the upper edge of the shaft and not coagulation loop.The patient was on general anesthesia and procedure was delayed (unspecified time) and could not be completed.The procedure was postponed and later cancelled to be scheduled for another day.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was confirmed that there was no patient injury due the reported event.However, the facility reported that consequently the patient will require a second round of anesthesia for the subsequent procedure.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the reported distorted image issue was not confirmed.However, the objective lens was displaced.Consequently, this caused an unclear image.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 year since the subject device was manufactured.Based on the results of the investigation, the reported distorted image was not confirmed.However, the displaced lens (which caused the unclear image) was likely due to excessive force by the user.This supplemental report includes a correction to b3, b5, and g2 to provide information that was inadvertently not included in the initial medwatch.An update has been made to d9 and h3.Also, information has been added to h4.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 4 MM, 12°, LONG
• Common Device Name: RIGID SCOPE
• 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: 19014342
• Report Number: 9610773-2024-00918
• Device Sequence Number: 12760850
• Product Code: GCP
• UDI-Device Identifier: 04042761051422
• UDI-Public: 04042761051422
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K897003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: WA20021A
• Device Lot Number: 800962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown