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

Model Number A4674A

Device Problem Material Deformation (2976)

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

Event Date 09/19/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, the telescope, displayed a blurry image.The issue was found during a diagnostic, hysteroscopy procedure.The procedure was completed with a similar device.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was found: the lens is damaged.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found a blurry image, a damaged lens, and a dented and tilted tube.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

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 damage to the objective lens was confirmed.The cause of the damaged objective lens was attributed to excessive force applied to the device.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE
• Type of Device: HYSTEROSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, deutschland 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, deutschland
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17883256
• MDR Text Key: 325249420
• Report Number: 9610773-2023-02826
• 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: K904939
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• 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: 712066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2016
• 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-S7.