MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE; OES THORACOSCOPE SYSTEM

Model Number WA53005A

Device Problems Break (1069); Mechanical Problem (1384)

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

Event Date 08/08/2023

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.In addition to the damaged plan glass at the distal end, due to damaged light guide fibers, the image had bad illumination.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation, or if any additional information is provided by the user facility.

Event Description

An olympus representative reported on behalf of the customer during reprocessing after the unidentified procedure they identified the cover glass was worn.The patient was not under sedation; therefore, there was no delay, and the procedure was completed with the same device.There was no patient harm, or user injury reported due to the event.The device was returned, and olympus repair center identified the plan glass at the distal end was damaged.This medical device report (mdr) is being submitted to capture the reportable malfunction found during the evaluation of the returned device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to correct g2 which has health professional incorrectly checked.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 excessive force by the customer.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE
• Type of Device: OES THORACOSCOPE SYSTEM
• 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: 17683301
• MDR Text Key: 322638271
• Report Number: 9610773-2023-02458
• Device Sequence Number: 1
• Product Code: EWY
• UDI-Device Identifier: 04042761052764
• UDI-Public: 04042761052764
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K912362
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA53005A
• Device Lot Number: 746714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2017
• 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