MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE; RIGID ENDOSCOPE TELESCOPE

Model Number A4674A

Device Problem Fracture (1260)

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

Event Date 06/24/2023

Event Type  malfunction  

Event Description

The customer reported that the eyepiece cover was fractured.The reported issue was observed while preparing the subject device, prior to an unspecified therapeutic procedure.The intended procedure was completed using another device.There was no harm or user injury reported due to the event.

Manufacturer Narrative

The subject device was returned to an olympus service center for evaluation.Upon inspection and testing of the returned device, the reported issue (broken eyepiece cover) was confirmed.The investigation is ongoing; therefore, a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

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 cause of the event likely occurred due to excessive force by the user.Olympus will continue to monitor field performance for this device.

Event Description

Additional clarification obtained identifies that the eyepiece cover was broken off.

Manufacturer Narrative

This report is being supplemented to correct and clarify information that was provided in the initial medwatch report.Correction to information provided in g3 of the initial medwatch report: the aware date (date received by manufacturer) should have been 08sep2023.

• Brand Name: TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE
• Type of Device: RIGID ENDOSCOPE TELESCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, germany 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: 17760826
• MDR Text Key: 323810272
• Report Number: 9610773-2023-02599
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 04042761006361
• UDI-Public: 04042761006361
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K790071
• 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,Followup
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A4674A
• Device Lot Number: 803278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2021
• 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
• Treatment: OTV-S190 VISERA ELITE VIDEO SYSTEM CENTER.