MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE ¿ULTRA¿, 4 MM, 30°, WITH TROCAR TUBE CONNECTOR; ULTRA TELESCOPES

Model Number WA4KA430

Device Problem Melted (1385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/09/2023

Event Type  malfunction  

Event Description

The customer reported that when using a telescope, ultra¿, 4 mm, 30°, with trocar tube connector, a black shadow was seen at the tip.The event occurred during preparation for use.The therapeutic procedure was completed with a similar device.There was no patient harm associated with the event.The device was returned and evaluated, and upon estimation, the lens was damaged.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.

Manufacturer Narrative

The device was returned and evaluated, and the customer¿s allegation (black shadow on tip) was confirmed.In addition, there was an image failure due to the lens damage.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

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 root cause of the event could not be determined although it can be presumed it was due to user error, improper handling as well as application of excessive force.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE ¿ULTRA¿, 4 MM, 30°, WITH TROCAR TUBE CONNECTOR
• Type of Device: ULTRA TELESCOPES
• 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: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17732667
• MDR Text Key: 323228887
• Report Number: 9610773-2023-02547
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 04042761083010
• UDI-Public: 04042761083010
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160249
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA4KA430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1