MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "ULTRA", 5.4 MM, 45°; RIGID SCOPE

Model Number	WA4KL545
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect medical device has already been returned to olympus.However, since the evaluation/investigation is still ongoing, the exact cause of the user's experience and the reported phenomenon has not been determined yet.This report will be updated if additional significant information becomes available or once the evaluation/investigation has been completed.
Event or Problem Description
Olympus was informed that during an unspecified procedure the adapter of the rigid scope broke off.No further information was provided but there was no report about an adverse event or patient injury.
Event or Problem Description
The intended procedure was a laparoscopy (lap) procedure and the procedure was completed.
Additional Manufacturer Narrative
Corrected fields: a1, b5 (information was inadvertently missed), d9 (date returned), g2, h3 ("not returned" should have not been selected), h6 (added component code), h6 (remove 4112 and 4110 under type of investigation as these codes should not have been selected).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 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 event occurred due to the use of excessive force by the customer.In addition, the following non-reportable malfunctions were found during the device evaluation: the image appeared blurry and the lens inside the optical system was damaged.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE "ULTRA", 5.4 MM, 45°
• 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
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662955
• MDR Report Key: 16572360
• Report Number: 9610773-2023-00809
• Device Sequence Number: 6126990
• Product Code: GCJ
• UDI-Device Identifier: 04042761082891
• UDI-Public: 04042761082891
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2023

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: WA4KL545
• Device Catalogue Number: WA4KL545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/17/2023
• Supplement Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 03/20/2023
• Supplement Report FDA Received Date: 05/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2019
• 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