MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 70°, 4 MM; HYSTEROSCOPE

Model Number A22003A

Device Problems Crack (1135); Material Separation (1562)

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

Event Date 11/21/2023

Event Type  malfunction  

Manufacturer Narrative

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

The customer reported to olympus, the rigid scope had a crack in the plastic part and separation.It is unknown when the issue was found.The device was returned for evaluation.During the device evaluation, it was found that the eyepiece was cracked.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

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, a definitive root cause of the reported cracked eyepiece issue could not be determined, however, the issue was likely due to repetitive use stress and or excessive force due to user handling/mishandling.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 70°, 4 MM
• Type of Device: HYSTEROSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18257114
• MDR Text Key: 329613481
• Report Number: 9610773-2023-03494
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761020862
• UDI-Public: 04042761020862
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K897003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22003A
• Device Lot Number: 555938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1