MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 12°, 4 MM; HYSTEROSCOPE, GYNECOLOGY

Model Number A22001A

Device Problem Break (1069)

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

Event Date 12/05/2023

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus for evaluation.In addition to the malfunction documented in b5, there was foreign material inside the lens.The illumination was bad due to burnt light guide connector.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.Establishment name:(b)(6).

Event Description

A customer reported to olympus, during reprocessing, the telescope lens was cracked.The intended unspecified therapeutic procedure was completed.There was no report of user or patient harm associate with this event.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was identified: the tip cover glass was cracked.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, the root cause of the event could not be determined although it can be presumed that it was caused wear and tear as well as excessive force.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 12°, 4 MM
• Type of Device: HYSTEROSCOPE, GYNECOLOGY
• 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: 18365313
• MDR Text Key: 331291521
• Report Number: 9610773-2023-03703
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761020848
• UDI-Public: 04042761020848
• 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,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22001A
• Device Lot Number: 708173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2015
• 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